FDA 510(k) Applications for Medical Device Product Code "IYN"
(System, Imaging, Pulsed Doppler, Ultrasonic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K103471 | ACCUTOME, INC. | UBM PLUS | 03/14/2011 |
| K211232 | Aco Healthcare Co,. Ltd. | Apache Ultrasound System | 06/25/2021 |
| K991805 | ACUSON CORP. | ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION | 08/02/1999 |
| K021497 | ACUSON CORP. | CYPRESS ULTRASOUND SYSTEM | 07/09/2002 |
| K022567 | ACUSON CORP. | SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM | 08/13/2002 |
| K172055 | Advanced Instrumentations, Inc | DUS-7000 Digital Color Doppler Ultrasound System | 08/31/2017 |
| K132059 | ADVANCED INSTRUMENTATIONS, INC. | DIAGNOSTIC ULTRASOUND SYSTEM | 10/25/2013 |
| K011224 | ADVANCED TECHNOLOGY LABORATORIES, INC. | HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY | 05/04/2001 |
| K001711 | AGILENT TECHNOLOGIES, INC. | M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1 | 06/20/2000 |
| K002470 | AGILENT TECHNOLOGIES, INC. | M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER | 09/08/2000 |
| K002397 | AGILENT TECHNOLOGIES, INC. | M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER | 08/17/2000 |
| K041916 | ALOKA CO. LTD USA | ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM | 07/30/2004 |
| K954022 | ALOKA CO., LTD. | ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM | 01/17/1996 |
| K080176 | ALOKA CO., LTD. | ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM | 02/29/2008 |
| K083254 | ALOKA CO., LTD. | ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM | 12/19/2008 |
| K110207 | ALOKA CO., LTD. | ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | 02/17/2011 |
| K060059 | ALOKA CO., LTD. | ALOKA SD-3500 ULTRASOUND SYSTEM | 01/13/2006 |
| K972465 | ALOKA CO., LTD. | ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM | 08/15/1997 |
| K963616 | ALOKA CO., LTD. | ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM | 04/03/1997 |
| K111227 | ALOKA CO., LTD. | ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM | 05/13/2011 |
| K023996 | ALOKA CO., LTD. | ALOKA SSD-3500 ULTRASOUND SYSTEM | 12/18/2002 |
| K003739 | ALOKA CO., LTD. | ALOKA SSD-4000 | 12/27/2000 |
| K033311 | ALOKA CO., LTD. | ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM | 10/29/2003 |
| K992663 | ALOKA CO., LTD. | ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM | 08/24/1999 |
| K011457 | ALOKA CO., LTD. | ALOKA SSD-5500 WITH KI AND A-SMA | 05/23/2001 |
| K043196 | ALOKA CO., LTD. | ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM | 11/30/2004 |
| K011315 | ALOKA CO., LTD. | SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5 | 05/15/2001 |
| K012080 | ALOKA CO., LTD. | SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM | 08/29/2001 |
| K142884 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE 12 | 10/28/2014 |
| K123610 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE 15 | 02/01/2013 |
| K150773 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE 15 Diagnostic Ultrasound System | 07/23/2015 |
| K142733 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE 5 | 10/28/2014 |
| K123611 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE 7 | 12/21/2012 |
| K132687 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE 7 | 11/27/2013 |
| K121729 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE 7 | 09/20/2012 |
| K120060 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE 9 | 03/16/2012 |
| K111864 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE 9 | 07/15/2011 |
| K121937 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE INNO | 07/26/2012 |
| K161439 | ALPINION MEDICAL SYSTEMS CO., LTD. | E-CUBE 11 | 09/21/2016 |
| K181277 | Alpinion Medical Systems Co., Ltd. | E-CUBE 12 | 09/28/2018 |
| K172732 | ALPINION MEDICAL SYSTEMS Co., Ltd. | E-CUBE 8 | 12/14/2017 |
| K181617 | Alpinion Medical Systems Co., Ltd. | E-CUBE 8 | 10/11/2018 |
| K153424 | ALPINION MEDICAL SYSTEMS CO., LTD. | E-CUBE i7 | 02/26/2016 |
| K182594 | Alpinion Medical Systems Co., Ltd. | E-CUBE i7 | 01/24/2019 |
| K182845 | Alpinion Medical Systems Co., Ltd. | minisono | 12/27/2018 |
| K223564 | Alpinion Medical Systems Co., Ltd. | X-CUBE 50, X-CUBE 60 | 04/17/2023 |
| K220857 | Alpinion Medical Systems Co., Ltd. | X-CUBE 50, X-CUBE 60 | 10/13/2022 |
| K211299 | Alpinion Medical Systems Co., Ltd. | X-CUBE 70 | 08/09/2021 |
| K200450 | Alpinion Medical Systems Co., Ltd. | X-Cube 70 | 07/10/2020 |
| K221093 | Alpinion Medical Systems Co., Ltd. | X-CUBE 70, X-CUBE 90 | 10/14/2022 |
| K211300 | Alpinion Medical Systems Co., Ltd. | X-CUBE 90 | 08/09/2021 |
| K200449 | Alpinion Medical Systems Co., Ltd. | X-Cube 90 | 07/10/2020 |
| K213523 | Alpinion Medical Systems Co., Ltd. | X-CUBE i8, X-CUBE i9 | 01/28/2022 |
| K002003 | ATL ULTRASOUND, INC. | HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING | 07/13/2000 |
| K182175 | Atys | TCD-X | 04/05/2019 |
| K012369 | ATYS MEDICAL | BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 | 08/10/2001 |
| K043554 | B-K MEDICAL A/S | ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 | 01/14/2005 |
| K043524 | B-K MEDICAL A/S | ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 | 01/13/2005 |
| K003986 | B-K MEDICAL A/S | ULTRASOUND SCANNER TYPE 2102 | 04/03/2001 |
| K024236 | B-K MEDICAL A/S | ULTRASOUND SCANNER, TYPE 2400 | 01/17/2003 |
| K100919 | B-K MEDICAL APS | PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 | 12/16/2011 |
| K123254 | B-K MEDICAL APS | ULTRASOUND SCANNER FLEX FOCUS | 02/13/2013 |
| K132335 | B-K MEDICAL APS | ULTRASOUND SCANNER FLEX FOCUS 1202 | 01/10/2014 |
| K132677 | B-K MEDICAL APS | ULTRASOUND SCANNER FLEX FOCUS 1202 | 01/07/2014 |
| K132685 | B-K MEDICAL APS | ULTRASOUND SCANNER PRO FOCUS 2202 | 01/06/2014 |
| K100402 | BARD ACCESS SYSTEMS, INC. | SITE-RITE VISION ULTRASOUND SYSTEM | 03/05/2010 |
| K160343 | BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD | SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner | 04/07/2016 |
| K121983 | BENQ MEDICAL TECHNOLOGY CORPATION | DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA | 09/07/2012 |
| K220169 | Bionet Co., Ltd. | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) | 10/11/2022 |
| K010405 | BIOSOUND ESAOTE, INC. | 7230 ULTRASOUND IMAGING SYSTEM WITH TEI | 03/13/2001 |
| K994369 | BIOSOUND ESAOTE, INC. | 7250 (MEGAS) | 02/24/2000 |
| K000931 | BIOSOUND ESAOTE, INC. | AU5 ULTRASOUND IMAGING SYSTEM | 06/08/2000 |
| K980468 | BIOSOUND ESAOTE, INC. | AU5 ULTRASOUND IMAGING SYSTEM | 08/26/1998 |
| K990360 | BIOSOUND ESAOTE, INC. | AU6 | 04/30/1999 |
| K014168 | BIOSOUND ESAOTE, INC. | AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) | 04/25/2002 |
| K023255 | BIOSOUND ESAOTE, INC. | TECHNOS MP, MODEL AU6 | 02/11/2003 |
| K161960 | BK MEDICAL APS | bk2300 | 10/17/2016 |
| K180737 | BK Medical ApS | Ultrasound Scanner System bk2300 | 08/01/2018 |
| K143298 | BK MEDICAL APS | Ultrasound Scanner System bk2300 | 01/16/2015 |
| K151910 | BK MEDICAL APS | Ultrasound Scanner System BK2300 | 10/05/2015 |
| K152052 | BK MEDICAL APS | Ultrasound Scanner System bk2300 | 09/16/2015 |
| K173569 | BK Medical ApS | Ultrasound System 1300 | 02/23/2018 |
| K222441 | BK Medical Aps | Ultrasound System 2300 | 12/07/2022 |
| K223830 | BK Medical Aps | Ultrasound System 2300 | 04/11/2023 |
| K063493 | BOSTON SCIENTIFIC CORP. | I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 | 12/21/2006 |
| K010649 | BRONCUS TECHNOLOGIES, INC. | EXHALE DOPPLER SYSTEM | 03/20/2001 |
| K090743 | BRONCUS TECHNOLOGIES, INC. | YIELD MINI DOPPLER SYSTEM | 04/03/2009 |
| K202406 | Butterfly Network, Inc. | Butterfly iQ Ultrasound System | 09/16/2020 |
| K163510 | BUTTERFLY NETWORK, INC. | Poseidon Ultrasound System | 09/06/2017 |
| K132942 | C.R. BARD, INC. | SITE-RITE VISION II ULTRASOUND SYSTEM | 10/17/2013 |
| K182427 | Canon Medical Systems Corporation | Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System | 11/02/2018 |
| K191663 | Canon Medical Systems Corporation | Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 | 09/18/2019 |
| K212960 | Canon Medical Systems Corporation | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 | 03/22/2022 |
| K202364 | Canon Medical Systems Corporation | Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 | 10/15/2020 |
| K201972 | Canon Medical Systems Corporation | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 | 10/08/2020 |
| K212333 | Canon Medical Systems Corporation | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | 01/24/2022 |
| K223017 | Canon Medical Systems Corporation | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 | 03/31/2023 |
| K202737 | Canon Medical Systems Corporation | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System | 10/16/2020 |
| K182679 | Canon Medical Systems Corporation | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 | 10/31/2018 |
| K191467 | Canon Medical Systems Corporation | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 | 07/19/2019 |
| K182596 | Canon Medical Systems Corporation | Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System | 11/02/2018 |
| K152467 | CARESTREAM HEALTH, INC. | Touch Ultrasound | 12/09/2015 |
| K090229 | CHANG GUNG MEDICAL SUPPLIES & EQUIPMENT CORP. | DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV | 03/13/2009 |
| K142982 | Chang Gung Medical Technology Co., Ltd. | OPUS 5100 Diagnostic Doppler Ultrasound System | 09/03/2015 |
| K102989 | CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC | OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS | 12/09/2010 |
| K120801 | CHISON MEDICAL IMAGING CO., LTD. | CHISON DIAGNOSTIC ULTRASOUND SYSTEM | 06/14/2012 |
| K131305 | CHISON MEDICAL IMAGING CO., LTD. | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE | 08/01/2013 |
| K140364 | CHISON MEDICAL IMAGING CO., LTD. | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE | 06/02/2014 |
| K113359 | CHISON MEDICAL IMAGING CO., LTD. | CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE | 02/03/2012 |
| K162172 | CHISON MEDICAL IMAGING CO., LTD. | EBit Series Diagnostic Ultrasound System | 09/14/2016 |
| K153085 | CHISON MEDICAL IMAGING CO., LTD. | Q Series Diagnostic Ultrasound System | 12/21/2015 |
| K150861 | CHISON MEDICAL IMAGING CO., LTD. | QBit Series Diagnostic Ultrasound System | 07/28/2015 |
| K170870 | CHISON Medical Imaging Co., Ltd. | Site~Rite Halcyon Diagnostic Ultrasound System | 07/06/2017 |
| K170374 | CHISON Medical Imaging Co., Ltd. | SonoBook Series Diagnostic Ultrasound System | 06/06/2017 |
| K121867 | CHISON MEDICAL IMAGING CO., LTD. | SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS | 08/02/2012 |
| K180974 | CHISON Medical Technologies Co., Ltd. | CBit Series Digital Color Doppler Ultrasound System | 08/17/2018 |
| K223570 | CHISON Medical Technologies Co., Ltd. | SonoAir Series Digital Color Doppler Ultrasound System | 03/31/2023 |
| K201965 | Chison Medical Technologies Co., Ltd. | SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System | 03/02/2021 |
| K201967 | Chison Medical Technologies Co., Ltd. | SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System | 02/26/2021 |
| K201968 | Chison Medical Technologies Co., Ltd. | SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System | 02/26/2021 |
| K201971 | Chison Medical Technologies Co., Ltd. | SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System | 02/25/2021 |
| K201969 | Chison Medical Technologies Co., Ltd. | SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System | 02/25/2021 |
| K200780 | CHISON Medical Technologies Co., Ltd. | XBit Series Digital Color Doppler Ultrasound System | 08/05/2020 |
| K213436 | Clarius Mobile Health Corp. | Clarius Ultrasound Scanner | 11/15/2021 |
| K232704 | Clarius Mobile Health Corp. | Clarius Ultrasound Scanner | 10/05/2023 |
| K180799 | Clarius Mobile Health Corp. | Clarius Ultrasound Scanner | 05/14/2018 |
| K192107 | Clarius Mobile Health Corp. | Clarius Ultrasound Scanner | 08/29/2019 |
| K163138 | Clarius Mobile Health Corp. | Clarius Ultrasound System | 11/30/2016 |
| K172385 | Clarius Mobile Health Corp. | Clarius Ultrasound System | 09/14/2017 |
| K202074 | Compal Electronics, Inc. | Apache Ultrasound System (Model C62) | 11/12/2020 |
| K051085 | COMPUMEDICS GERMANY GMGH | DOPPLER-BOX | 05/05/2005 |
| K203657 | Crystalline Medical | Vu-Path Ultrasound System | 06/25/2021 |
| K990517 | DIAGNOSTIC MEDICAL SYSTEMS | EXPLORER CVS TRANSCRANIAL DOPPLER | 08/01/2000 |
| K951998 | DIASONICS ULTRASOUND | DIASONICS MASTERS SERIES 5000 ULTRASOUND SCANNER | 03/27/1996 |
| K041915 | DWL ELEKTRONISCHE SYSTEME GMBH | HEMO-DOP | 08/04/2004 |
| K232336 | E-Scopics | ES Series V2 | 09/26/2023 |
| K213102 | E-Scopics | ES1 System | 01/11/2022 |
| K193518 | EchoNous, Inc. | KOSMOS | 03/26/2020 |
| K212100 | EchoNous, Inc. | Kosmos | 08/06/2021 |
| K991872 | ECTON, INC. | LYNX ULTRASOUND SYSTEM | 06/16/1999 |
| K162055 | EDAN INSTRUMENTS INC | Acclarix LX8 Diagnostic Ultrasound System | 01/31/2017 |
| K160790 | Edan Instruments Inc | Acclarix LX8 Diagnostic Ultrasound System | 04/04/2016 |
| K172380 | Edan Instruments Inc | U2 Diagnostic Ultrasound System | 09/29/2017 |
| K171900 | Edan Instruments, Inc | Acclarix AX4 Diagnostic Ultrasound System | 08/18/2017 |
| K192879 | Edan Instruments, Inc | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System | 05/21/2020 |
| K180862 | Edan Instruments, Inc | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System | 05/24/2018 |
| K123249 | EDAN INSTRUMENTS, INC. | DIAGNOSTIC ULTRASOUND SYSTEM | 02/08/2013 |
| K202856 | Edan Instruments, Inc. | Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, A | 01/25/2021 |
| K173003 | Edan Instruments, Inc. | U50 Diagnostic Ultrasound System | 11/15/2017 |
| K142511 | EDAN INSTRUMENTS, INC. | U50 Diagnostic Ultrasound System | 02/20/2015 |
| K180408 | Edan Instruments, Inc. | U60 Diagnostic Ultrasound System | 04/13/2018 |
| K935024 | ELSCINT, INC. | ESI-5000 | 06/12/1996 |
| K073709 | EP MEDSYSTEMS | MODIFICATION TO VIEWMATE SYSTEM | 03/11/2008 |
| K031066 | EP MEDSYSTEMS | VIEWMATE ULTRASOUND IMAGING SYSTEM | 10/17/2003 |
| K083882 | ESAOTE EUROPE B.V. | MYLABFIVE | 01/30/2009 |
| K101605 | ESAOTE EUROPE B.V. | MYLABONE ULTRASOUND SYSTEM | 08/31/2010 |
| K141486 | ESAOTE EUROPE B.V. | MYLABSIX ULTRASOUND SYSTEM | 07/11/2014 |
| K161168 | Esaote Europe B.V. | MyLabSix Ultrasound System | 09/02/2016 |
| K163082 | ESAOTE S.P.A | 6200 Ultrasound System and 6250 Ultrasound System | 03/16/2017 |
| K161359 | Esaote S.p.A | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System | 07/19/2016 |
| K173291 | Esaote S.p.A | 6440 Ultrasound System | 01/12/2018 |
| K133905 | ESAOTE S.P.A. | 6200 / 6250 ULTRASOUND SYSTEM | 04/15/2014 |
| K153277 | Esaote S.p.A. | 6200 Ultrasound System and 6250 Ultrasound System | 05/04/2016 |
| K212021 | Esaote S.p.A. | 6430 MyLabX75, 6430 MyLab XPro75 | 09/16/2021 |
| K191072 | Esaote S.p.A. | 7410 Ultrasound System (MyLabSigma) | 06/10/2019 |
| K081386 | ESAOTE S.P.A. | MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) | 09/25/2008 |
| K091009 | ESAOTE S.P.A. | MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 | 05/18/2009 |
| K052805 | ESAOTE S.P.A. | MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 | 10/17/2005 |
| K132466 | ESAOTE S.P.A. | MYLABSEVEN 6400, MYLABALPHA 7400 | 12/04/2013 |
| K142008 | ESAOTE S.P.A. | MYLABSEVEN, MYLABALPHA | 09/12/2014 |
| K162290 | ESAOTE S.P.A. | MyLabSix CrystaLine | 10/14/2016 |
| K140677 | ESAOTE S.P.A. | MYLABSSOGNO | 04/25/2014 |
| K040596 | ESAOTE S.P.A. | ULTRASOUND IMAGING SYSTEM, MODEL 7300 | 03/31/2004 |
| K103152 | ESAOTE, S.P.A. | 6250 ULTRASOUND SYTEMS | 01/07/2011 |
| K190989 | Esaote, S.p.A. | 6400 Ultrasound System (MyLabX6, MyLabX7) | 05/10/2019 |
| K183191 | Esaote, S.p.A. | 6420 Ultrasound System | 12/04/2018 |
| K192157 | Esaote, S.p.A. | 6450 Ultrasound system | 11/22/2019 |
| K050326 | ESAOTE, S.P.A. | 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 | 02/28/2005 |
| K081794 | ESAOTE, S.P.A. | MODEL 7340 ULTRASOUND SYSTEM | 07/10/2008 |
| K051308 | ESAOTE, S.P.A. | MYLAB 70 ULTRASOUND IMAGING SYSTEM | 06/01/2005 |
| K051837 | ESAOTE, S.P.A. | MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 | 07/20/2005 |
| K060827 | ESAOTE, S.P.A. | MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100 | 05/19/2006 |
| K142077 | ESAOTE, S.P.A. | MYLABGAMMA | 09/12/2014 |
| K111302 | ESAOTE, S.P.A. | MYLABSEVEN, MYLABALPHA | 07/22/2011 |
| K132231 | ESAOTE, S.P.A. | MYLABSEVEN, MYLABALPHA | 11/27/2013 |
| K121384 | ESAOTE, S.P.A. | MYLABSOGNO | 05/23/2012 |
| K100931 | ESAOTE, S.P.A. | MYLABTWICE, MODEL 6200 | 06/25/2010 |
| K093613 | ESCALON MEDICAL CORP. | VASCUVIEW TAP ULTRASOUND SYSTEM | 12/23/2009 |
| K192303 | Exact Imaging Inc. | ExactVu High Resolution Micro-Ultrasound System | 10/01/2019 |
| K190995 | Exact Imaging, Inc. | ExactVu High Resolution Micro-Ultrasound System | 05/10/2019 |
| K211527 | Exo Imaging Inc. | Exo Iris | 08/20/2021 |
| K222198 | Exo Imaging Inc. | Exo Iris (El2001) | 11/09/2022 |
| K140254 | EZONO AG | EZONO 4000 | 02/26/2014 |
| K220295 | FUJIFILM Healthcare Corporation | ARIETTA 50 | 04/29/2022 |
| K202160 | FUJIFILM SonoSite Inc. | Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System | 09/01/2020 |
| K160406 | FUJIFILM SonoSite, Inc. | FUJIFILM FC1 Ultrasound System | 03/16/2016 |
| K160674 | FUJIFILM SONOSITE, INC. | Fujifilm Sonosite Vevo MD Imaging System | 04/19/2016 |
| K190476 | FUJIFILM SonoSite, Inc. | FUJIFILM Sonosite Vevo MD Imaging System | 03/15/2019 |
| K180704 | FUJIFILM SonoSite, Inc. | SonoSite iViz Ultrasound System | 04/13/2018 |
| K162288 | FUJIFILM SONOSITE, INC. | SonoSite iViz Ultrasound System | 09/08/2016 |
| K200964 | FUJIFILM SonoSite, Inc. | Sonosite PX Ultrasound System | 05/08/2020 |
| K213763 | FUJIFILM Sonosite, Inc. | Sonosite PX Ultrasound System | 12/27/2021 |
| K160734 | FUJIFILM SonoSite, Inc. | SonoSite SII Ultrasound System | 04/05/2016 |
| K183235 | FUJIFILM SonoSite, Inc. | SonoSite SII Ultrasound System | 02/07/2019 |
| K162045 | FUJIFILM SonoSite, Inc. | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | 08/18/2016 |
| K171437 | FujiFilm SonoSite, Inc. | SonoSite X-Porte Ultrasound System | 06/12/2017 |
| K142017 | FUJIFILM SonoSite, Inc. | X-PORTE ULTRASOUND SYSTEM | 08/22/2014 |
| K152983 | FUJIFILM SONOSITE,INC. | FUJIFILM SonoSite iViz Ultrasound System | 11/12/2015 |
| K152209 | FUJIFILM SONOSITE,INC. | FUJIFILM SonoSite X-Porte Ultrasound System | 08/19/2015 |
| K153626 | FUJIFILM SONOSITE,INC. | SonoSite Edge II Ultrasound System | 01/20/2016 |
| K133454 | FUJIFILM SONOSITE,INC. | SONOSITE EDGE ULTRASOUND SYSTEM | 12/16/2013 |
| K161119 | FUJIFILM SONOSITE,INC. | SonoSite iViz Ultrasound System | 05/13/2016 |
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| K150080 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S | 06/12/2015 |
| K170277 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System | 03/23/2017 |
| K113647 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM | 12/16/2011 |
| K173471 | Shenzhen Mindray Bio-medical Electronics Co., LTD | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic | 01/08/2018 |
| K192152 | Shenzhen Mindray Bio-Medical Electronics Co., LTD | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System | 12/13/2019 |
| K190206 | Shenzhen Mindray Bio-medical Electronics Co., LTD | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | 03/08/2019 |
| K132779 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM | 11/19/2013 |
| K140030 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM | 02/19/2014 |
| K123503 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM | 12/13/2012 |
| K110199 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM | 02/08/2011 |
| K120699 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM | 04/19/2012 |
| K183660 | Shenzhen Mindray Bio-Medical Electronics Co., LTD | DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System | 04/09/2019 |
| K130833 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | 06/21/2013 |
| K200643 | Shenzhen Mindray Bio-Medical Electronics Co., LTD | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous | 07/24/2020 |
| K080640 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | M5 DIAGNOSTIC ULTRASOUND SYSTEM | 03/21/2008 |
| K083001 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | M5 DIAGNOSTIC ULTRASOUND SYSTEM | 10/22/2008 |
| K171579 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd | M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System | 10/18/2017 |
| K121010 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM | 04/19/2012 |
| K103677 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM | 01/31/2011 |
| K100830 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM | 05/05/2010 |
| K172970 | ShenZhen Mindray Bio-Medical Electronics Co., Ltd | M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound | 10/25/2017 |
| K152543 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd | M9/M9CV/M9T Diagnostic Ultrasound System | 10/29/2015 |
| K210416 | Shenzhen Mindray Bio-Medical Electronics Co., LTD | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | 06/10/2021 |
| K200001 | Shenzhen Mindray Bio-Medical Electronics Co., LTD | MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System | 04/09/2020 |
| K172860 | ShenZhen Mindray Bio-Medical Electronics Co., Ltd | Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System | 01/02/2018 |
| K152763 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | 10/21/2015 |
| K210699 | Shenzhen Mindray Bio-Medical Electronics Co., LTD | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound Syst | 06/10/2021 |
| K220051 | Shenzhen Mindray Bio-Medical Electronics Co., LTD | TE Air Diagnostic Ultrasound System | 03/04/2022 |
| K143472 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | TE7 Diagnostic Ultrasound System | 01/02/2015 |
| K160381 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | TE7 Diagnostic Ultrasound System | 03/09/2016 |
| K161525 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd | TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System | 07/13/2016 |
| K180912 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd | TE7/TE5 Diagnostic Ultrasound System | 07/30/2018 |
| K203391 | Shenzhen Mindray Bio-Medical Electronics Co., LTD | TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System | 03/23/2021 |
| K130695 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | Z5 DIAGNOSTIC ULTRASOUND SYSTEM | 06/19/2013 |
| K200251 | ShenZhen Mindray Bio-Medical Electronics Co., Ltd | Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System | 04/02/2020 |
| K182603 | Shenzhen Mindray Bio-medical Electronics Co., LTD | Z6 Diagnostic Ultrasound System | 11/14/2018 |
| K122010 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | Z6 DIAGNOSTIC ULTRASOUND SYSTEM | 07/20/2012 |
| K192410 | ShenZhen Mindray Bio-Medical Electronics Co., Ltd | ZS3 and z.one pro Ultrasound Systems | 12/19/2019 |
| K171891 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd | ZS3 Ultrasound System, z.one pro Ultrasound System | 09/21/2017 |
| K163690 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | 04/20/2017 |
| K201693 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | 08/21/2020 |
| K200979 | Shenzhen Mindray Bio-Medical Electronics Co., LTD. | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System | 05/28/2020 |
| K171034 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System | 07/10/2017 |
| K212900 | Shenzhen Mindray Bio-Medical Electronics Co., LTD. | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | 11/05/2021 |
| K200411 | Shenzhen Mindray Bio-Medical Electronics Co., LTD. | Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System | 04/08/2020 |
| K221300 | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona O | 09/29/2022 |
| K162845 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System | 12/15/2016 |
| K230768 | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | 06/09/2023 |
| K162267 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | 09/06/2016 |
| K222928 | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9 | 02/07/2023 |
| K212265 | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | 11/16/2021 |
| K220242 | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | 03/25/2022 |
| K141010 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., CO. LTD | M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM | 05/14/2014 |
| K173369 | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd | DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System | 12/13/2017 |
| K171233 | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | 09/12/2017 |
| K202785 | Shenzhen Mindray Bio-Meidcal Electronics Co., LTD | Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System | 04/08/2021 |
| K222754 | Shenzhen Mindray Bio-Meidcal Electronics Co., LTD | ViewMate Multi Ultrasound System | 11/09/2022 |
| K182165 | Shenzhen Well.D Medical Electronics Co., LTD. | Color Doppler Ultrasound System; Model: mEye1 and mEye2 | 12/20/2018 |
| K230066 | Shenzhen Wisonic Medical Technology Co., Ltd. | Carnation series Diagnostic Ultrasound System | 09/15/2023 |
| K163712 | SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. | Clover 50/Clover60/Clover70 Diagnostic Ultrasound System | 01/02/2018 |
| K180461 | Shenzhen Wisonic Medical Technology Co., Ltd. | Navi e/Navi s/Navi X Diagnostic Ultrasound System | 05/09/2018 |
| K191347 | Shenzhen Wisonic Medical Technology Co., Ltd. | Paragon XHD Diagnostic Ultrasound System | 02/07/2020 |
| K182715 | Shenzhen Wisonic Medical Technology Co., Ltd. | Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System | 11/20/2018 |
| K210154 | Shenzhen Wisonic Medical Technology Co.,Ltd. | Labat series Diagnostic Ultrasound System | 07/30/2021 |
| K211886 | Shenzhen Wisonic Medical Technology Co.Ltd. | Clivia series Diagnostic Ultrasound System | 12/02/2021 |
| K003515 | SHIMADZU MEDICAL SYSTEMS | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 | 02/12/2001 |
| K061643 | SHIMADZU MEDICAL SYSTEMS | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | 07/27/2006 |
| K003514 | SHIMADZU MEDICAL SYSTEMS | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 | 02/12/2001 |
| K061637 | SHIMADZU MEDICAL SYSTEMS | ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO | 07/25/2006 |
| K050510 | SHIMADZU MEDICAL SYSTEMS | ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | 04/01/2005 |
| K172162 | Siemens Healthcare | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | 08/16/2017 |
| K183575 | Siemens Healthineers | ACUSON S3000, S2000 Diagnostic Ultrasound System | 03/20/2019 |
| K121138 | SIEMENS MEDICAL SOLUTION | ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM | 05/17/2012 |
| K170315 | Siemens Medical Solutions Inc. | Acuson SC2000 Diagnostic Ultrasound System | 04/04/2017 |
| K162221 | Siemens Medical Solutions Inc. Ultrasound Group | ACUSON SC2000 Diagnostic Ultrasound System | 09/06/2016 |
| K123622 | SIEMENS MEDICAL SOLUTIONS USA INC. | ACUSON | 12/05/2012 |
| K050240 | SIEMENS MEDICAL SOLUTIONS USA INC. | MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM | 02/15/2005 |
| K061980 | SIEMENS MEDICAL SOLUTIONS USA INC. | SIEMENS ACUSON X500 ULTRASOUND SYSTEM | 08/17/2006 |
| K200644 | Siemens Medical Solutions USA, Inc | ACUSON Freestyle Diagnostic Ultrasound System | 04/10/2020 |
| K210743 | Siemens Medical Solutions USA, Inc | ACUSON Redwood Diagnostic Ultrasound System | 04/01/2021 |
| K181098 | Siemens Medical Solutions USA, Inc | ACUSON SC2000 Diagnostic Ultrasound System | 05/31/2018 |
| K200707 | Siemens Medical Solutions USA, Inc | ACUSON Sequoia Diagnostic Ultrasound System | 04/15/2020 |
| K201462 | Siemens Medical Solutions USA, Inc | ACUSON Sequoia Diagnostic Ultrasound System | 06/24/2020 |
| K211859 | Siemens Medical Solutions USA, Inc | ACUSON Sequoia Diagnostic Ultrasound System | 07/20/2021 |
| K221500 | Siemens Medical Solutions USA, Inc | ACUSON Sequoia Diagnostic Ultrasound System | 06/14/2022 |
| K193257 | Siemens Medical Solutions USA, Inc | ACUSON Sequoia Diagnostic Ultrasound System | 01/31/2020 |
| K223735 | Siemens Medical Solutions USA, Inc | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System | 02/06/2023 |
| K131164 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON | 12/24/2013 |
| K111674 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON | 06/30/2011 |
| K122825 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON | 09/28/2012 |
| K042044 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON CV70 CARDIOVASCULAR SYSTEM | 08/13/2004 |
| K032111 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON CV70 CARDIOVASCULAR SYSTEM | 07/18/2003 |
| K052331 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON CYPRESS ULTRASOUND SYSTEM | 11/10/2005 |
| K230207 | Siemens Medical Solutions USA, Inc. | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System | 02/13/2023 |
| K180039 | Siemens Medical Solutions USA, Inc. | ACUSON Juniper Diagnostic Ultrasound System | 02/01/2018 |
| K201130 | Siemens Medical Solutions USA, Inc. | ACUSON Juniper Diagnostic Ultrasound System | 05/26/2020 |
| K221190 | Siemens Medical Solutions USA, Inc. | ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System | 08/16/2022 |
| K172374 | Siemens Medical Solutions USA, Inc. | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | 08/15/2017 |
| K161787 | Siemens Medical Solutions USA, Inc. | ACUSON NX2 Diagnostic Ultrasound Systems | 07/28/2016 |
| K173957 | Siemens Medical Solutions USA, Inc. | ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System | 02/01/2018 |
| K063761 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM | 01/04/2007 |
| K191922 | Siemens Medical Solutions USA, Inc. | ACUSON P200 Diagnostic Ultrasound System | 08/15/2019 |
| K083114 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON P50 ULTRASOUND SYSTEM | 03/31/2009 |
| K150050 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON P500 Diagnostic Ultrasound System | 02/09/2015 |
| K213487 | Siemens Medical Solutions USA, Inc. | ACUSON P500 Ultrasound System | 02/11/2022 |
| K163396 | Siemens Medical Solutions USA, Inc. | ACUSON P500 Ultrasound System | 01/04/2017 |
| K130619 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM | 03/21/2013 |
| K140959 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS | 04/30/2014 |
| K142876 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | 10/23/2014 |
| K130881 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON S2000 AND S3000 | 10/11/2013 |
| K130739 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS | 06/06/2013 |
| K093812 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | 03/03/2010 |
| K051139 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM | 05/13/2005 |
| K052410 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON SEQUOIA ULTRASOUND SYSTEM | 09/22/2005 |
| K070576 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON X150 ULTRASOUND SYSTEM | 03/26/2007 |
| K061946 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM | 07/21/2006 |
| K121699 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM | 06/22/2012 |
| K123001 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM | 10/26/2012 |
| K141846 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM | 08/07/2014 |
| K180067 | Siemens Medical Solutions USA, Inc. | ACUSON X800 Diagnostic Ultrasound System | 02/07/2018 |
| K042055 | SIEMENS MEDICAL SOLUTIONS USA, INC. | CYPRESS ULTRASOUND SYSTEM | 08/16/2004 |
| K001400 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM | 08/01/2000 |
| K063138 | SIEMENS MEDICAL SOLUTIONS USA, INC. | MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM | 11/22/2006 |
| K042770 | SIEMENS MEDICAL SOLUTIONS USA, INC. | MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM | 10/20/2004 |
| K102017 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | 09/20/2010 |
| K032114 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM | 07/21/2003 |
| K041319 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM | 06/07/2004 |
| K050034 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM | 01/13/2005 |
| K023720 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SONOLINE ANTARES ULTRASOUND SYSTEM | 11/20/2002 |
| K033196 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SONOLINE ANTARES WITH CLARIFY VE | 10/16/2003 |
| K003125 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM | 10/20/2000 |
| K980557 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING | 04/24/1998 |
| K040060 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS | 01/28/2004 |
| K052894 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SONOLINE G60 S ULTRASOUND SYSTEM | 11/23/2005 |
| K043016 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM | 11/16/2004 |
| K132804 | SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO | ACUSON S1000 / S2000 / S3000 | 10/24/2013 |
| K121646 | SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO | ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM | 06/22/2012 |
| K173981 | Siemens Medical Solutions USA, Inc. Ultrasound Group | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | 02/02/2018 |
| K163635 | Siemens Medical Solutions USA, Inc. Ultrasound Group | ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems | 01/12/2017 |
| K063803 | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI | ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM | 01/05/2007 |
| K082142 | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | 11/13/2008 |
| K112596 | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | 09/16/2011 |
| K113179 | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | 12/07/2011 |
| K080760 | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI | ACUSON X300 ULTRASOUND SYSTEM | 04/25/2008 |
| K071036 | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI | MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM | 05/16/2007 |
| K072365 | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI | SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM | 10/17/2007 |
| K072090 | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI | SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS | 09/14/2007 |
| K162417 | Siemens Medical Solutions, Inc. | Acuson Freestyle Ultrasound System | 09/28/2016 |
| K093531 | SIEMENS MEDICAL SOLUTIONS, INC. | ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM | 12/01/2009 |
| K162243 | Siemens Medical Solutions, Inc. | ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System | 09/06/2016 |
| K090334 | SIEMENS MEDICAL SOLUTIONS, INC. | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | 02/20/2009 |
| K130754 | SIEMENS MEDICAL SOLUTIONS, INC. | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | 03/25/2013 |
| K142628 | SIEMENS MEDICAL SOLUTIONS, INC. | Acuson SC2000 Diagnostic Ultrasound System | 10/10/2014 |
| K152469 | SIEMENS MEDICAL SOLUTIONS, INC., ULTRASOUND DIVISION | ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System | 09/21/2015 |
| K232617 | Siemens Medical Solutions, USA, Inc | ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System | 09/26/2023 |
| K192835 | Siemens Medical Solutions, USA, Inc. | ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System | 10/22/2019 |
| K200585 | Siemens Medical Solutions, USA, Inc. | Acuson SC2000 Diagnostic Ultrasound System | 04/22/2020 |
| K202683 | Siemens Medical Solutions, USA, Inc. | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnos | 10/15/2020 |
| K152369 | SIEMENS MEDICAL SOLUTIONS, USA, INC. ULTRASOUND GROUP | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | 10/06/2015 |
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| K152250 | Signostics Limited | SpeqRT | 09/03/2015 |
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| K112997 | SILICON VALLY MEDICAL INSTRUMENTS, INC. | HD-IVUS ULTRASOUND IMAGING SYSTEM | 12/17/2011 |
| K230365 | Sonio | Sonio Detect | 07/25/2023 |
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| K130801 | SONOSCAPE COMPANY LIMITED | DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | 06/14/2013 |
| K131213 | SONOSCAPE COMPANY LIMITED | DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | 06/21/2013 |
| K131088 | SONOSCAPE COMPANY LIMITED | PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | 05/24/2013 |
| K130119 | SONOSCAPE COMPANY LIMITED | PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | 04/12/2013 |
| K142474 | SONOSCAPE COMPANY LIMITED | S12 Digital Color Doppler Ultrasound System | 12/19/2014 |
| K110510 | SONOSCAPE COMPANY LIMITED | S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | 05/16/2011 |
| K142815 | SONOSCAPE COMPANY LIMITED | S22 Digital Color Doppler Ultrasound System | 01/28/2015 |
| K150045 | SONOSCAPE COMPANY LIMITED | S30/S40 Digital Color Doppler Ultraound System | 04/28/2015 |
| K112602 | SONOSCAPE COMPANY LIMITED | S6 DIAGNOSTIC ULTRASOUND SYSTEM | 11/07/2011 |
| K112451 | SONOSCAPE COMPANY LIMITED | S8 DIAGNOSTIC ULTRASOUND SYSTEM | 09/16/2011 |
| K132768 | SONOSCAPE COMPANY LIMITED | S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | 10/04/2013 |
| K142714 | SONOSCAPE COMPANY LIMITED | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System | 01/29/2015 |
| K142710 | SONOSCAPE COMPANY LIMITED | S9 Portable Digital Color Doppler Ultrasound System | 01/05/2015 |
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| K170303 | SONOSCAPE MEDICAL CORP. | E5 Series Digital Color Doppler Ultrasound System | 05/19/2017 |
| K173058 | Sonoscape Medical Corp. | P10 Series Digital Color Doppler Ultrasound System | 12/01/2017 |
| K221089 | Sonoscape Medical Corp. | P12 Elite Series Digital Color Doppler Ultrasound System | 09/15/2022 |
| K221140 | Sonoscape Medical Corp. | P20 Elite Series Digital Color Doppler Ultrasound System | 09/13/2022 |
| K172993 | Sonoscape Medical Corp. | P20 Series Digital Color Doppler Ultrasound System | 12/05/2017 |
| K170999 | SONOSCAPE MEDICAL CORP. | P50 Series Digital Color Doppler Ultrasound System | 07/12/2017 |
| K171000 | SONOSCAPE MEDICAL CORP. | P60 Series Digital Color Doppler Ultrasound System | 07/11/2017 |
| K152396 | SONOSCAPE MEDICAL CORP. | S12 Digital Color Doppler Ultrasound System | 09/03/2015 |
| K160283 | SONOSCAPE MEDICAL CORP. | S45 Digital Color Doppler Ultrasound System | 04/04/2016 |
| K152854 | SONOSCAPE MEDICAL CORP. | S50 Digital Color Doppler Ultrasound System | 01/13/2016 |
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| K172082 | Sonoscape Medical Corp. | S60 Series Digital Color Doppler Ultrasound System | 09/21/2017 |
| K152164 | SONOSCAPE MEDICAL CORP. | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System | 08/28/2015 |
| K152165 | SONOSCAPE MEDICAL CORP. | S9 Portable Digital Color Doppler Ultrasound System | 08/26/2015 |
| K222596 | Sonoscape Medical Corp. | S90 Exp Series Digital Color Doppler Ultrasound System | 02/10/2023 |
| K163427 | SONOSCAPE MEDICAL CORP. | X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System | 01/03/2017 |
| K160258 | SONOSCAPE MEDICAL CORP. | X5 Digital Color Doppler Ultrasound System | 04/01/2016 |
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| K990806 | SONOSITE,INC. | C1 ULTRASOUND SYSTEM | 03/26/1999 |
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| K021628 | SONOSITE,INC. | SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES) | 05/31/2002 |
| K003399 | SONOSITE,INC. | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM | 11/16/2000 |
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| K043559 | SONOSITE,INC. | SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | 01/12/2005 |
| K082098 | SONOSITE,INC. | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | 08/25/2008 |
| K053069 | SONOSITE,INC. | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | 11/16/2005 |
| K092058 | SONOSITE,INC. | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | 10/02/2009 |
| K102390 | SONOSITE,INC. | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | 11/19/2010 |
| K030949 | SONOSITE,INC. | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM | 04/07/2003 |
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| K033367 | SONOSITE,INC. | TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464 | 11/05/2003 |
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| K132171 | SUPERSONIC IMAGINE | AIXPLORER | 09/24/2013 |
| K132274 | SUPERSONIC IMAGINE | AIXPLORER | 09/24/2013 |
| K112255 | SUPERSONIC IMAGINE | AIXPLORER | 08/28/2012 |
| K142100 | SUPERSONIC IMAGINE | AIXPLORER | 11/20/2014 |
| K161999 | SUPERSONIC IMAGINE | Aixplorer | 11/16/2016 |
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| K180572 | Supersonic Imagine | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 | 05/29/2018 |
| K222191 | SuperSonic Imagine | Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 | 10/28/2022 |
| K203645 | SuperSonic Imagine | Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 | 06/29/2021 |
| K091970 | SUPERSONIC IMAGINE | AIXPLORER ULTRASOUND SYSTEM | 08/12/2009 |
| K171105 | Supersonic Imagine | AIXPLORER« & AIXPLORER« Ultimate Ultrasound Systems | 07/11/2017 |
| K202455 | Supersonic Imagine | Aixplorer«MACH20, Aixplorer«MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems | 12/29/2020 |
| K211248 | Telemed | ArtUs | 02/11/2022 |
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| K112953 | TERATECH CORP. | TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS | 02/03/2012 |
| K051334 | TERATECH CORP. | TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER | 06/03/2005 |
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