FDA 510(k) Applications for Medical Device Product Code "IYO"
(System, Imaging, Pulsed Echo, Ultrasonic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K963863 | 3D ULTRASOUND, INC. | JANUS I | 04/21/1997 |
| K043189 | 3G ULTRASOUND, INC. | SONALIS, MODEL 2000 | 02/09/2005 |
| K991469 | AAC CONSULTING GROUP, INC. | AWARE PAD | 07/20/1999 |
| K042752 | ACCUTOME ULTRASOUND, INC. | ACCUPACH V | 11/10/2004 |
| K070943 | ACCUTOME ULTRASOUND, INC. | B-SCAN PLUS | 04/19/2007 |
| K152573 | ACCUTOME, INC. | 4Sight | 11/25/2015 |
| K123349 | ACCUTOME, INC. | A-SCAN PLUS CONNECT | 01/29/2013 |
| K032956 | ACCUTOME, INC. | ACCUSONIC A-SCAN MODEL, 24-4000 | 10/10/2003 |
| K050552 | ACCUTOME, INC. | PACHPEN PACHYMETER, MODEL 24-5100 | 03/28/2005 |
| K002807 | ACUSON CORP. | 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING | 12/01/2000 |
| K010950 | ACUSON CORP. | CYPRESS SYSTEM | 06/27/2001 |
| K992580 | ACUSON CORP. | FETAL ASSESSMENT CAP | 10/18/1999 |
| K973767 | ACUSON CORP. | HARMONIC IMAGING WITH CONTRAST | 12/23/1997 |
| K161354 | AdEcho Tech | MELODY, Remote Control System for Ultrasound Probe | 06/12/2017 |
| K112022 | ADVANCED INSTRUMENTATIONS, INC. | DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | 09/22/2011 |
| K172931 | Advanced Instrumentations, Inc. | DUS-6000 Digital Ultrasonic Diagnostic Imaging System | 12/01/2017 |
| K991671 | ADVANCED TECHNOLOGY LABORATORIES, INC. | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | 06/18/1999 |
| K961459 | ADVANCED TECHNOLOGY LABORATORIES, INC. | LEVEL 10 HDI | 03/26/1997 |
| K992470 | ADVANCED TECHNOLOGY LABORATORIES, INC. | ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM | 08/23/1999 |
| K990198 | ALLIANCE MEDICAL, INC. | AMIB7 | 06/29/1999 |
| K951976 | ALLIANCE MEDICAL, INC. | ECHO. AKHO | 07/26/1996 |
| K032875 | ALOKA CO. LTD USA | ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM | 09/30/2003 |
| K040719 | ALOKA CO., LTD. | ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY | 03/26/2004 |
| K093488 | ALOKA CO., LTD. | ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM | 11/20/2009 |
| K020668 | ALOKA CO., LTD. | ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124 | 07/10/2002 |
| K983879 | ALOKA CO., LTD. | ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM | 03/22/1999 |
| K012253 | ALOKA CO., LTD. | SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM | 08/30/2001 |
| K121888 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE 15 | 07/26/2012 |
| K042250 | ALUNA MANAGEMENT CO., LTD. | SENSATOUCH | 11/12/2004 |
| K140126 | ANALOGIC CORPORATION | SONIC WINDOW | 03/04/2014 |
| K161342 | ANALOGIC CORPORATION | Sonic Window | 06/15/2016 |
| K153416 | ARCSCAN, INC. | ArcScan Insight 100 | 02/02/2016 |
| K060800 | Ardent Sound, Inc. | SEEKER/SPARK ULTRASOUND SYSTEM | 04/07/2006 |
| K092182 | Ardent Sound, Inc. | VOYAGER COMPACT IMAGING SYSTEM | 10/09/2009 |
| K050551 | Ardent Sound, Inc. | VOYAGER PERSONAL IMAGING DEVICE | 03/22/2005 |
| K961073 | ATLANTIS DIAGNOSTICS INTL., INC. | ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) | 02/19/1997 |
| K980860 | ATLANTIS DIAGNOSTICS INTL., INC. | HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM | 04/02/1998 |
| K171528 | Avantsonic Technology Co., Ltd. | Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) | 01/24/2018 |
| K000567 | B & K MEDICAL A/S | ULTRASOUND SCANNER TYPE 2102 | 03/09/2000 |
| K991937 | B & K MEDICAL A/S | ULTRASOUND SCANNER, MODEL TYPE 2101 | 07/30/1999 |
| K002085 | B & K MEDICAL A/S | ULTRASOUND SCANNER, TYPE 1101 | 08/01/2000 |
| K003041 | B-K MEDICAL A/S | ULTRASOUND SCANNER TYPE 2101 | 02/07/2001 |
| K023457 | B-K MEDICAL A/S | ULTRASOUND SCANNER, TYPE 1101 | 11/01/2002 |
| K011417 | B-K MEDICAL A/S | ULTRASOUND SCANNER, TYPE 2102 | 06/08/2001 |
| K081154 | B-K MEDICAL APS | ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 | 05/23/2008 |
| K132346 | B-K MEDICAL APS | ULTRASOUND SCANNER PRO FOCUS 2202 | 01/10/2014 |
| K070077 | B-K MEDICAL APS | ULTRASOUND SCANNER PROFOCUS, MODEL 2202 | 03/05/2007 |
| K140428 | B-K MEDICAL APS | ULTRASOUND SCANNER SYSTEM BK2300 | 05/30/2014 |
| K943315 | B&K MEDICAL | ULTRASOUND SCANNER 2002 | 02/09/1996 |
| K211193 | Bard Access Systems, Inc, (C.R. Bard, Inc.) | BD Prevue II Peripheral Vascular Vascular Access System | 06/25/2021 |
| K120882 | BARD ACCESS SYSTEMS, INC. | SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE | 05/30/2012 |
| K231283 | Bard Access Systems, Inc. (C.R. Bard, Inc.) | SiteRiteÖ 9 Ultrasound System | 09/11/2023 |
| K000960 | BARZELL-WHITMORE MAROON BELLS, INC. | BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900 | 05/26/2000 |
| K173138 | Biim Ultrasound AS | Biim Diagnostic Ultrasound System | 10/27/2017 |
| K012084 | BIO MEDI COM | SONOREAL 3D | 09/26/2001 |
| K023473 | BIO MEDI COM | SONOREAL 3D | 11/20/2002 |
| K020068 | BIO MEDI COM | SONOREAL 3D SYSTEM | 03/04/2002 |
| K130944 | BIOBOT SURGICAL PTE LTD | ISR'OBOT MONA LISA | 06/07/2013 |
| K203659 | Biobot Surgical Pte Ltd | iSR'obot Mona Lisa 1.0 | 07/08/2021 |
| K213411 | Biobot Surgical Pte Ltd | iSRÆobot Mona Lisa 2.0 | 12/22/2021 |
| K111347 | BIOBOT SURGICAL PTE LTD | ISROBOT MONA LISA | 08/12/2011 |
| K981293 | BIOSOUND ESAOTE, INC. | 7200 ULTRASOUND IMAGING SYSTEM | 06/30/1998 |
| K982444 | BIOSOUND ESAOTE, INC. | 7250 ULTRASOUND IMAGING SYSTEM | 10/06/1998 |
| K000681 | BIOSOUND ESAOTE, INC. | AU5, AU6 | 05/03/2000 |
| K953530 | BIOSOUND, INC. | DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A | 04/08/1996 |
| K152316 | BOSTON SCIENTIFIC | iLab Ultrasound Imaging System | 09/18/2015 |
| K982840 | BOSTON SCIENTIFIC CORP. | BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING | 11/09/1998 |
| K980851 | BOSTON SCIENTIFIC CORP. | GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 | 04/22/1998 |
| K123535 | BOSTON SCIENTIFIC CORP. | ILAB ULTRASOUND IMAGING SYSTEM | 01/15/2013 |
| K130243 | BOSTON SCIENTIFIC CORP. | ILAB ULTRASOUND IMAGING SYSTEM | 03/01/2013 |
| K072517 | BOSTON SCIENTIFIC CORP. | ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 | 09/26/2007 |
| K200980 | Butterfly Network, Inc. | Auto 3D Bladder Volume Tool | 06/11/2020 |
| K220068 | Butterfly Network, Inc. | Butterfly iQ/iQ+ Ultrasound System | 03/31/2023 |
| K182281 | C.R. Bard | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech | 10/24/2018 |
| K142443 | C.R. Bard, Inc | Site-Rite 6 Ultrasound System with Pinpoint GT Technology | 10/30/2014 |
| K150529 | C.R. Bard, Inc | Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System | 03/30/2015 |
| K071204 | C.R. BARD, INC. | SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 | 05/18/2007 |
| K152554 | C.R. Bard, Inc. | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology | 12/14/2015 |
| K131227 | CARENOSO TECHNOLOGY CO., LTD. | PADSCAN HD SERIES BLADDER SCANNER | 07/12/2013 |
| K153581 | Caresono Technology Co., Ltd. | Bladder Scanner | 04/08/2016 |
| K150342 | CARESTREAM HEALTH, INC. | Touch Ultrasound | 05/08/2015 |
| K012727 | CARL ZEISS OPHTHALMIC SYSTEMS, INC. | HUMPHREY OCT3 | 01/31/2002 |
| K993978 | CAROLINA MEDICAL, INC. | PR3 ULTRASOUND SYSTEM | 02/10/2000 |
| K101429 | CERACARTA SPA | ECO SUPERGEL | 09/15/2010 |
| K050167 | CHISON MEDICAL IMAGING CO., LTD. | CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE | 02/08/2005 |
| K072210 | CHISON MEDICAL IMAGING CO., LTD. | CHISON, MODEL 8300 | 08/24/2007 |
| K222787 | Chongqing Sunkingdom Medical Instrument Co., Ltd | Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P | 01/09/2023 |
| K092619 | CIVCO | ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER | 11/13/2009 |
| K143396 | CIVCO Medical Instruments Co Inc dba CIVCO Medical Solutions | omni TRAX Active Patient Tracker | 01/23/2015 |
| K141806 | CLEAR GUIDE MEDICAL | CLEAR GUIDE ONE | 09/19/2014 |
| K170856 | Contec Medical Systems Co., LTD. | CMS600P2 B-Ultrasound Diagnostic System | 11/17/2017 |
| K090773 | CONTOUR FABRICATORS, INC. | CFI ULTRASOUND PROBE DRAPE | 09/18/2009 |
| K983945 | CORTEX TECHNOLOGY APS | CORTEX DERMASCAN C ULTRASONIC SYSTEM | 03/17/1999 |
| K142329 | dBMEDx INC. | BBS REVOLUTION | 12/15/2014 |
| K172256 | Delphinus Medical Technologies | SoftVue | 03/02/2018 |
| K123209 | DELPHINUS MEDICAL TECHNOLOGIES, INC | SOFTVUE | 12/19/2013 |
| K142517 | DELPHINUS MEDICAL TECHNOLOGIES, INC | SoftVue | 10/31/2014 |
| K033385 | DGH TECHNOLOGY, INC. | DGH 55 HANDHELD PACHYMETER (PACHMATE) | 11/07/2003 |
| K093371 | DGH TECHNOLOGY, INC. | MODEL DGH 6000 SCANMATE A | 04/05/2010 |
| K171301 | DGH Technology, Inc. | Scanmate Flex | 07/31/2017 |
| K963585 | DIAGNOSTIC ULTRASOUND CORP. | BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 | 10/01/1996 |
| K955840 | DIAGNOSTIC ULTRASOUND CORP. | BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 | 05/24/1996 |
| K955942 | DIAGNOSTIC ULTRASOUND CORP. | BLADDERSCAN BVI 5000 | 03/15/1996 |
| K022153 | DIAGNOSTIC ULTRASOUND CORP. | BLADDERSCAN BVI 6100 | 08/15/2002 |
| K030763 | DIAGNOSTIC ULTRASOUND CORP. | DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM | 03/26/2003 |
| K962662 | DIASONICS, INC. | VINGMED SOUND COLOR FLOW MAPPING SYSTEM | 01/02/1997 |
| K990248 | DICOMIT IMAGING SYSTEMS CORP. | DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION | 04/16/1999 |
| K192573 | Dolphin Medical Imaging, LLC | Dolphin Medical Imaging USB Ultrasound System | 11/19/2019 |
| K993624 | DYMAX CORP. | SITE-RITE 3 ULTRASOUND SYSTEM | 11/10/1999 |
| K032135 | DYMAX CORP. | SITE-RITE IV ULTRASOUND SYSTEM | 07/21/2003 |
| K013142 | DYNAMIC IMAGING LTD. | DIASUS | 10/05/2001 |
| K212851 | Echolight S.p.A | EchoSK and EchoSGyn modules for EchoS Family devices | 03/16/2022 |
| K181574 | EchoNous, Inc. | Uscan | 07/10/2018 |
| K150239 | Echosens | FibroScan | 09/01/2015 |
| K150949 | ECHOSENS | FibroScan | 06/03/2015 |
| K123806 | ECHOSENS | FIBROSCAN | 04/05/2013 |
| K212035 | Echosens | FibroScan 230 | 07/30/2021 |
| K172142 | Echosens | FibroScan 430 Mini+ | 09/13/2017 |
| K160524 | ECHOSENS | FibroScan 530 Compact | 03/18/2016 |
| K200655 | Echosens | FibroScan« 630 | 07/16/2020 |
| K223902 | Echosens | FibroScan« device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) | 03/02/2023 |
| K203273 | Echosens | FibroScan« Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) | 03/25/2021 |
| K173034 | Echosens | FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | 11/14/2017 |
| K181547 | Echosens | FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | 07/09/2018 |
| K980308 | ECHOTECH 3D IMAGING SYSTEMS GMBH | ECHOTECH 3D FREESCAN | 05/06/1998 |
| K013088 | ECHOTECH 3D IMAGING SYSTEMS, INC. | ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS | 04/04/2002 |
| K982800 | ECTON, INC. | ECTON LYNX ULTRASOUND SYSTEM | 09/22/1998 |
| K171824 | Edan Instruments Inc | Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System | 07/18/2017 |
| K161300 | EDAN INSTRUMENTS INC. | Acclarix AX8 Diagnostic Ultrasound System | 05/31/2016 |
| K190186 | Edan Instruments, Inc. | Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System | 03/28/2019 |
| K150999 | EDAN INSTRUMENTS, INC. | Acclarix Diagnostic Ultrasound System | 05/06/2015 |
| K192791 | Edan Instruments, Inc. | Diagnostic Ultrasound System | 11/27/2019 |
| K131830 | EDAN INSTRUMENTS, INC. | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | 09/17/2013 |
| K122574 | EDAN INSTRUMENTS, INC. | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 | 10/12/2012 |
| K190786 | Ellex Medical Pty Ltd. | Eye Prime | 04/11/2019 |
| K083061 | ELLEX, INC. | ELLEX INNOVATIVE IMAGING EYE CUBED V4 | 01/09/2009 |
| K103608 | ELLEX, INC. | I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND | 12/27/2010 |
| K192170 | Emagine Solutions Technology, LLC | VistaScan USB Ultrasound Imaging System | 01/23/2020 |
| K963290 | ENDOSONICS CORP. | COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | 08/06/1997 |
| K965223 | ENDOSONICS CORP. | RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | 06/29/1998 |
| K041639 | ENVISIONEERING, LLC. | TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM | 09/02/2004 |
| K110688 | ESAOTE | MYLABGOLD | 06/02/2011 |
| K061755 | ESAOTE EUROPE B.V. | MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM | 08/07/2006 |
| K071996 | ESAOTE S.P.A. | MYLAB30, MODEL 7300 | 08/03/2007 |
| K080049 | ESCALON MEDICAL CORP. | VASCUVIEW ULTRASOUND SYSTEM | 01/23/2008 |
| K162972 | Exact Imaging | ExactVu High Resolution Micro-Ultrasound System | 12/02/2016 |
| K180636 | Exact Imaging Inc. | ExactVu High Resolution Micro-Ultrasound System | 04/30/2018 |
| K210468 | FCU Co., Ltd. | SC1 Handheld Ultrasound Imaging System (Model: SC1) | 07/23/2021 |
| K971528 | FUJINON, INC. | ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY) | 12/12/1997 |
| K990401 | FUKUDA DENSHI USA, INC. | FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER | 10/15/1999 |
| K981404 | FUKUDA DENSHI USA, INC. | FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 | 05/20/1998 |
| K955543 | FUKUDA DENSHI USA, INC. | ULTRASOUND SYSTEM MODEL UF-3500 | 02/11/1997 |
| K102393 | GE MEDICAL SYSTEM ISRAEL LTD. | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM | 11/05/2010 |
| K970901 | GE MEDICAL SYSTEMS | GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM | 12/22/1997 |
| K000571 | GE MEDICAL SYSTEMS | GE LOGIQ 700 | 04/18/2000 |
| K964617 | GE MEDICAL SYSTEMS | GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM | 10/03/1997 |
| K960700 | GE MEDICAL SYSTEMS | LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM | 08/28/1996 |
| K091374 | GE MEDICAL SYSTEMS CHINA CO., LTD. | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND | 05/26/2009 |
| K092140 | GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. | GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND | 08/21/2009 |
| K082185 | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA | GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 | 08/15/2008 |
| K000695 | GE MEDICAL SYSTEMS, INC. | GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM | 03/16/2000 |
| K992208 | GE MEDICAL SYSTEMS, INC. | GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM | 07/12/1999 |
| K000516 | GE MEDICAL SYSTEMS, INC. | GE LOGIQ 700 | 04/19/2000 |
| K993364 | GE MEDICAL SYSTEMS, INC. | GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION | 11/05/1999 |
| K993365 | GE MEDICAL SYSTEMS, INC. | GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION | 11/05/1999 |
| K990226 | GE MEDICAL SYSTEMS, INC. | GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW | 02/09/1999 |
| K991842 | GE VINGMED ULTRASOUND | SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING | 06/11/1999 |
| K101149 | GE VINGMED ULTRASOUND AS | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | 10/13/2010 |
| K120201 | GE VINGMED ULTRASOUND AS | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | 04/19/2012 |
| K993069 | GENERAL ELECTRIC CO. | GE DIASONICS GATEWAY AND GATEWAY FX | 09/22/1999 |
| K991611 | GENERAL ELECTRIC CO. | GE LOGIQ 500 | 06/09/1999 |
| K012560 | GENERAL ELECTRIC CO. | GE LOGIQ A100 MP, MODEL 2272413 | 08/23/2001 |
| K072797 | GENERAL ELECTRIC CO. | GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND | 10/17/2007 |
| K061682 | GENERAL ELECTRIC CO. | GE VOLUSON E8 ULTRASOUND SYSTEM | 07/12/2006 |
| K014206 | GENERAL ELECTRIC CO. | LOGIQBOOK | 01/16/2002 |
| K953752 | GENERAL ELECTRIC CO. | RT55 DIAGNOSTIC ULTRASOUND SYSTEM | 03/15/1996 |
| K172750 | Guangzhou Sonostar Technologies Co., Ltd. | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) | 02/28/2018 |
| K140899 | HALO MEDICAL TECHNOLOGIES, LLC | HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM | 05/05/2014 |
| K151339 | HEALCERION CO., LTD. | SONON Ultrasound Imaging System (Model: SONON 300C) | 09/10/2015 |
| K963706 | HEWLETT-PACKARD CO. | PHILIPS SONO DIAGNOST 800 | 03/19/1997 |
| K974457 | HEWLETT-PACKARD CO. | SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T | 07/14/1998 |
| K980687 | HEWLETT-PACKARD CO. | SONOS 5500 ULTRASOUND IMAGING SYSTEM | 05/22/1998 |
| K952540 | HEWLETT-PACKARD CO. | SONOS IMAGING SYSTEM (2000/2500 & 1000/1500) | 03/11/1996 |
| K011252 | HITACHI MEDICAL CORP. | EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM | 05/30/2001 |
| K962308 | HITACHI MEDICAL CORP. OF AMERICA | EUB-905 | 07/17/1996 |
| K093466 | HITACHI MEDICAL SYSTEMS AMERICA, INC. | HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS | 06/17/2010 |
| K022928 | HUDSON DIAGNOSTIC IMAGING LLC | HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS | 12/11/2002 |
| K142054 | IMACOR INC. | IMACOR ZURA EVO IMAGING SYSTEM | 09/29/2014 |
| K080223 | IMACOR LLC | ZURA TEE SYSTEM | 06/24/2008 |
| K970156 | IMEX MEDICAL SYSTEMS, INC. | IMEX FUTURALDOP PRO | 04/04/1997 |
| K213303 | Infraredx, Inc. | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 | 12/07/2021 |
| K121479 | INNEROPTIC TECHNOLOGY, INC | AIM | 09/13/2012 |
| K083728 | INNEROPTIC TECHNOLOGY, INC | INVISION SYSTEM | 08/12/2009 |
| K041947 | INNOVATIVE IMAGING, INC. | I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND | 08/16/2004 |
| K950330 | INTERNATIONAL IMAGING ELECTRONICS | DIGITAL IMAGE ACQUISITION SYSTEM | 05/07/1996 |
| K961229 | INTERNATIONAL ULTRASOUND CORP. | HR12000 ULTRASOUND SYSTEM | 05/29/1997 |
| K973450 | INVENTIVE PRODUCTS, INC. | SENSOR PAD | 11/14/1997 |
| K011095 | IODP SA | MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM | 06/13/2001 |
| K213620 | iSono Health, Inc. | ATUSAÖ Automated 3D Breast Ultrasound System | 04/22/2022 |
| K961029 | KILTEX CORP. | KILTEX PROBE COVER | 07/25/1996 |
| K151060 | KONICA MINOLTA, INC. | Ultrasound System SONIMAGE HS1 | 06/05/2015 |
| K182153 | KONICA MINOLTA, INC. | Ultrasound System SONIMAGE HS1 | 09/06/2018 |
| K180084 | Konica Minolta, Inc. | Ultrasound System SONIMAGE MX1 | 02/08/2018 |
| K951449 | KOVEN TECHNOLOGY, INC. | MODEL KM-25 | 05/20/1996 |
| K963274 | KOVEN TECHNOLOGY, INC. | V-LINK 3.2 FOR WINDOWS | 10/31/1996 |
| K000320 | KPI ULTRASOUND, LLC. | SONOS AIRES 600 (SA-600) | 05/02/2000 |
| K081781 | LABORIE MEDICAL TECHNOLOGIES, CORP | NUWAV | 07/09/2008 |
| K950943 | LECTEC CORP. | ULTRA EASE | 03/07/1996 |
| K112539 | LEIKER REGULATORY & QUALITY CONSULTING | CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE | 01/30/2012 |
| K990560 | LIFE IMAGING SYSTEMS, INC. | LIFE IMAGING SYSTEMS, MODEL L3DI | 05/20/1999 |
| K093485 | LIFE-TECH, INC. | VESISCAN | 03/16/2010 |
| K183173 | Lightmed USA, Inc | LIGHTMED Ultrasound System | 07/01/2019 |
| K170761 | Lightmed USA, Inc. | LIGHTSonic BUBM | 04/13/2018 |
| K170046 | Lilium Otsuka Co., Ltd. | Lilium a-200E | 12/07/2017 |
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| K153369 | VOLCANO CORPORATION | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz | 12/22/2015 |
| K060483 | VOLCANO CORPORATION | VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM | 06/23/2006 |
| K140291 | VOLCANO CORPORATION | VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS | 03/07/2014 |
| K143122 | Volcano Corporation | Volcano iFR Harvest Software (Offline) | 02/20/2015 |
| K133323 | VOLCANO CORPORATION | VOLCANO IFR MODALITY | 03/14/2014 |
| K150441 | VOLCANO CORPORATION | Volcano iFR Modality, iFR Scout feature | 03/20/2015 |
| K133142 | VOLCANO CORPORATION | VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION | 11/15/2013 |
| K051920 | VOLCANO CORPORATION | VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 | 08/19/2005 |
| K123898 | VOLCANO CORPORATION | VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM | 01/14/2013 |
| K061215 | VOLCANO CORPORATION | VOLCANO S51 FAMILY OF IMAGING SYSTEMS | 08/10/2006 |
| K113486 | VOLCANO CORPORATION | VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM | 01/27/2012 |
| K111706 | VOLCANO CORPORATION | VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM | 07/15/2011 |
| K042188 | VOLCANO THERAPEUTICS, INC. | VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM | 11/10/2004 |
| K992378 | VOLUMETRICS MEDICAL IMAGING, INC. | DIAGNOSTIC ULTRASOUND, MODEL 1.0 | 09/29/1999 |
| K202119 | Weipeng (Suzhou) Medical Devices Co., Ltd. | AcuSee AS-P1000 System | 10/07/2020 |
| K150580 | WINPROBE CORPORATION | UltraVision 2 Diagnostic Ultrasound System | 04/07/2015 |
| K200136 | Wuxi Hisky Medical Technologies Co., Ltd. | Shear Wave Quantificational Ultrasound Diagnostic System | 03/17/2020 |
| K173595 | Wuxi Hisky Medical Technologies Co., Ltd. | Shear Wave Quantificational Ultrasound Diagnostic System | 06/22/2018 |
| K223448 | Xuzhou Kaixin Electronic Instrument Co., Ltd. | Bladder Scanner Model: BVT02 | 07/07/2023 |
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