FDA 510(k) Applications for Medical Device Product Code "ITX"
(Transducer, Ultrasonic, Diagnostic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K973079 | ACUSON CORP. | L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM | 11/05/1997 |
| K223689 | Advance Medical Designs, Inc. | Disposable Needle Guides and Grids | 08/02/2023 |
| K011265 | ADVANCE MEDICAL DESIGNS, INC. | ULTRASOUND TRANSDUCER COVER | 10/30/2001 |
| K072285 | ALOKA CO., LTD. | ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM | 08/30/2007 |
| K964549 | ALOKA CO., LTD. | ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER | 06/03/1997 |
| K002784 | ALOKA CO., LTD. | ALOKA UST-5280-5 | 09/20/2000 |
| K974544 | ALOKA CO., LTD. | ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER | 03/18/1998 |
| K011314 | ALOKA CO., LTD. | OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM | 05/15/2001 |
| K955893 | AMEDIC AB | EVERYTIME TRANSFUCER COVER | 12/30/1997 |
| K011581 | AMERTEK MEDICAL, INC. | AMERITEK BRACHYTHERAPY TEMPLATE | 07/17/2001 |
| K030518 | AMERTEK MEDICAL, INC. | AMERITEK SURE-POINT TRACKER SYSTEM | 05/20/2003 |
| K955668 | ARLANDA MEDICINSKA INSTRUMENT CO. AB | INTRACAVITY NEEDLE GUIDE KIT | 07/30/1997 |
| K050320 | ASCENDIA MEDTECH AB | FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT | 08/15/2005 |
| K994373 | ATL ULTRASOUND, INC. | HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4) | 03/24/2000 |
| K083667 | B-K MEDICAL APS | NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 | 02/02/2009 |
| K042445 | BARD ACCESS SYSTEMS, INC. | SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT | 10/19/2004 |
| K972672 | BARZELL-WHITMORE MAROON BELLS, INC. | BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY | 07/29/1997 |
| K163502 | Biobot Surgical Pte Ltd | iSR'obot Biopsy Kit | 05/16/2017 |
| K971942 | BIOSOUND ESAOTE, INC. | SLED, FINGER, HANDLE | 07/23/1997 |
| K971700 | BIOSOUND, INC. | BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER | 07/09/1997 |
| K953819 | BIOSOUND, INC. | DIAGNOSTIC ULTRASOUND TRANDUCER | 03/01/1996 |
| K953759 | BIOSOUND, INC. | DIAGNOSTIC ULTRASOUND TRANSDUCER | 03/01/1996 |
| K953716 | BIOSOUND, INC. | INTRACAVITY TRANSDUCERS | 04/17/1996 |
| K953579 | BIOSOUND, INC. | TEE PROBE | 02/02/1996 |
| K955458 | BIOSOUND, INC. | ULTRASOUND PROBE BIOPSY ACCESSORIES | 02/12/1996 |
| K113832 | BLACKTOE MEDICAL III, INC. | SONICEYE ULTRASOUND TRANSDUCER | 03/06/2012 |
| K152403 | BOSTON SCIENTIFIC | Permanent Sled Bag | 09/22/2015 |
| K073623 | BOSTON SCIENTIFIC CORP. | ATLANTIS 018 PERIPHERAL IMAGING CATHETER | 03/13/2008 |
| K080272 | BOSTON SCIENTIFIC CORP. | ATLANTIS PVIMAGING CATHETER, MODEL H749364560 | 03/11/2008 |
| K123424 | BOSTON SCIENTIFIC CORP. | MDU5 PLUS STERILE BAG | 02/20/2013 |
| K041818 | BOSTON SCIENTIFIC CORP. | SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 | 11/10/2004 |
| K060947 | BOSTON SCIENTIFIC CORP. | SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 | 04/19/2006 |
| K200733 | Boston Scientific Corporation | Opticross 35 15 MHz Peripheral Imaging Catheter | 04/17/2020 |
| K022860 | BOSTON SCIENTIFIC, TARGET | ATLANTIS PV IMAGING CATHETER, MODEL 36456 | 11/21/2002 |
| K070195 | BROADSOUND CORPORATION | BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B | 10/15/2007 |
| K171348 | C.R. Bard, Inc. | Pinpoint GT Needle Guide Kits | 05/22/2017 |
| K052517 | C.R. BARD, INC. | SITE-RITE 5 ULTRASOUND SYSTEM | 09/29/2005 |
| K050724 | C.R. BARD, INC. | SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM | 04/18/2005 |
| K951567 | CARDIOMETRICS, INC. | CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE | 10/25/1996 |
| K973713 | CARDIOVASCULAR DYNAMICS, INC. | 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR | 01/23/1998 |
| K963989 | CARDIOVASCULAR DYNAMICS, INC. | P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE | 04/24/1997 |
| K970049 | CARDIOVASCULAR IMAGING SYSTEMS, INC. | BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ | 06/20/1997 |
| K091877 | CHISON MEDICAL IMAGING CO., LTD. | CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL | 09/02/2009 |
| K093713 | CIVCO MEDICAL INSTRUMENTS | ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM | 01/19/2010 |
| K163313 | CIVCO MEDICAL INSTRUMENTS CO., INC. | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor | 06/09/2017 |
| K211270 | CIVCO Medical Instruments Co., Inc. | CIV-Clear cover | 09/13/2021 |
| K970514 | CIVCO MEDICAL INSTRUMENTS CO., INC. | DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE | 06/20/1997 |
| K131161 | CIVCO MEDICAL INSTRUMENTS CO., INC. | EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, | 09/17/2013 |
| K970515 | CIVCO MEDICAL INSTRUMENTS CO., INC. | GENERAL PURPOSE LATEX TRANSDUCER COVERS | 06/20/1997 |
| K991236 | CIVCO MEDICAL INSTRUMENTS CO., INC. | GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER, | 06/02/1999 |
| K970513 | CIVCO MEDICAL INSTRUMENTS CO., INC. | GENERAL PURPOSE TRANDUCER COVER | 06/20/1997 |
| K992152 | CIVCO MEDICAL INSTRUMENTS CO., INC. | GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF | 08/17/1999 |
| K131528 | CIVCO MEDICAL INSTRUMENTS CO., INC. | NON-PYROGENIC ULTRASOUND TRANSDUCER COVER | 06/11/2013 |
| K013721 | CIVCO MEDICAL INSTRUMENTS CO., INC. | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER | 12/28/2001 |
| K160806 | CIVCO MEDICAL INSTRUMENTS CO., INC. | Verza Guidance System | 08/05/2016 |
| K222052 | CIVCO Medical Instruments Co., Inc. | VitroPRO | 11/22/2022 |
| K190802 | CIVCO Medical Solutions | Envision ultrasound pad and cover | 05/24/2019 |
| K974301 | CLK INTL., INC. | CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER | 02/06/1998 |
| K171272 | Cook Incorporated | Cook-Swartz Doppler Flow Probe | 07/17/2018 |
| K022649 | COOK VASCULAR, INC. | COOK-SWARTZ DOPPLER FLOW PROBE | 09/06/2002 |
| K002958 | COOK VASCULAR, INC. | SHAPEABLE DOPPLER FLOW PROBE | 12/18/2001 |
| K160414 | Corbin Clinical Resources, LLC | Precision Point Biopsy Needle Guide | 08/01/2016 |
| K070515 | CORDATEC N.V. | A-VIEW BASIC AND PLUS | 07/30/2007 |
| K980091 | COSMACEUTICAL MARKETING, INC. | LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60 | 04/09/1998 |
| K972152 | DEVMED CORP. | DEVMED STEPPING AND STABILIZING SYSTEM | 08/15/1997 |
| K982568 | DIAGNOSTIC ULTRASOUND CORP. | BLADDERMANAGER PCI 5000 MODEL 1002 | 01/25/1999 |
| K961002 | DIASONICS ULTRASOUND | DIASONICS ITNRAOPERATIVE PROBES | 01/22/1997 |
| K961757 | ECO-MED PHARMACEUTICALS, INC. | ECOGEL 100 ULTRASOUND GEL | 07/25/1996 |
| K955246 | ECO-MED PHARMACEUTICALS, INC. | ECOGEL 200 ULTRASOUND GEL | 02/21/1996 |
| K962840 | ECO-MED PHARMACEUTICALS, INC. | ECOLOTION TRANSMISSION AND MASSAGE LOTION | 12/23/1996 |
| K091680 | EDAN INSTRUMENTS, INC. | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | 06/19/2009 |
| K110999 | EDAN INSTRUMENTS, INC. | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | 04/26/2011 |
| K962293 | ENDOSONICS CORP. | ENDOSONICS AUTOMATIC PULL BACK DEVICE | 09/16/1996 |
| K982329 | ENDOSONICS CORP. | VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) | 01/14/1999 |
| K041638 | ENVISIONEERING, LLC. | TARGETSCAN BIOPSY KIT | 09/02/2004 |
| K041637 | ENVISIONEERING, LLC. | TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM | 09/01/2004 |
| K070903 | ESAOTE EUROPE B.V. | MYLAB40 | 07/02/2007 |
| K080119 | ESI, INC. | CLEARSCAN | 02/21/2008 |
| K082893 | ESI, INC. | PRAGER SHELL | 12/05/2008 |
| K211969 | Exact Medical Manufacturing | EMM Ultrasonic Transducer Cover | 08/13/2021 |
| K222460 | Exact Medical Manufacturing | Intraoperative Ultrasound Probe Cover | 05/12/2023 |
| K110202 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. | FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB | 02/08/2011 |
| K110920 | FUKUDA DENSHI CO., LTD. | UF-760AG | 04/08/2011 |
| K081919 | FUKUDA DENSHI CO., LTD. | UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM | 09/09/2008 |
| K122921 | GE HEALTHCARE | C1-6-D ULTRASOUND TRANSDUCER | 10/05/2012 |
| K122515 | GE HEALTHCARE | C2-9-D ULTRASOUND TRANSDUCER | 09/11/2012 |
| K121062 | GE MEDICAL SYSTEM ISRAEL LTD. | VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM | 08/17/2012 |
| K001016 | GE MEDICAL SYSTEMS | GE LOGIQ 700 | 04/24/2000 |
| K202035 | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Vscan Air | 11/20/2020 |
| K141093 | GE VINGMED ULTRASOUND AS | 6VT-D ULTRASOUND TRANSDUCER | 05/15/2014 |
| K092756 | GE VINGMED ULTRASOUND AS | GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM | 09/28/2009 |
| K053463 | GEORGENE AUSTRIA | AIM ACCURACY IN MARKING SYSTEM | 03/07/2006 |
| K170741 | GEOTEK Medikal Ltd Sti | GTK Disposable Needle Guides | 06/01/2017 |
| K213087 | Global Protection Corp. | Natural Rubber Latex Ultrasound Transducer Probe Covers | 06/07/2022 |
| K061153 | GYNESONICS, INC. | GYNESONICS EC6 TRANSDUCER | 10/27/2006 |
| K972348 | HEWLETT-PACKARD CO. | HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM | 07/24/1997 |
| K990400 | HEWLETT-PACKARD CO. | LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM | 02/24/1999 |
| K970034 | HEWLETT-PACKARD CO. | SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM | 03/17/1997 |
| K971116 | HEWLETT-PACKARD CO. | SONOS 5500 IMAGING SYSTEM | 01/12/1998 |
| K110752 | HIGHLAND INSTRUMENTS | HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER | 06/28/2011 |
| K142618 | Hitachi Aloka Medical America, Inc. | Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System | 10/16/2014 |
| K152126 | HITACHI ALOKA MEDICAL AMERICA, INC. | UST-5550-R; UST-5536-R; L43K | 08/17/2016 |
| K140854 | HITACHI ALOKA MEDICAL, LTD. | INTRA-OPERATIVE ULTRASOUND TRANSDUCER | 06/11/2014 |
| K013723 | HITACHI MEDICAL CORP. | MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER | 02/06/2002 |
| K981434 | HITACHI MEDICAL CORP. OF AMERICA | EUP-OL334 LAPARASCOPICPROBE | 07/27/1998 |
| K221278 | Hony Medical Co., Ltd. | Transducer Probe Cover | 01/11/2023 |
| K111426 | HOUSTON MEDICAL ROBOTICS | EUCLID (TM) TIER 1-GW ACCESS SYSTEM | 03/01/2012 |
| K083824 | HUMANSCAN COMPANY, LTD. | HUMANSCAN M5S-D ULTRASOUND TRANSDUCER | 02/10/2009 |
| K201425 | Huntleigh Healthcare Limited | Disposable Intraoperative Probe (DIOP8) | 02/19/2021 |
| K032315 | HUNTLEIGH HEALTHCARE, INC. | IOP8 INTRA OPERATIVE PROBE | 11/18/2004 |
| K981069 | INTERNATIONAL MEDICAL PRODUCTS B.V. | ULTRA-COVER PU-TRANSDUCER COVER | 09/23/1998 |
| K080555 | IVU IMAGING CORPORATION | SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) | 06/03/2008 |
| K982208 | JOMED IMAGING LTD. | IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER | 08/27/1999 |
| K180970 | Koelis | Disposable guides KDNG00 | 07/10/2018 |
| K141334 | KOELIS | REUSABLE GUIDE | 07/11/2014 |
| K171040 | Koelis | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range | 07/31/2017 |
| K011284 | MARTIN E. WENDELKEN | THIN FILM DRESSING FOR ULTRASOUND EXAM | 06/20/2001 |
| K111021 | MCUBE TECHNOLOGY CO., LTD. | CUBESCAN / BIOCON-700 | 04/27/2011 |
| K964001 | MED INSTITUTE, INC. | SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM | 04/17/1998 |
| K992305 | MEDI-STIM A/S | MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 | 09/08/1999 |
| K061560 | MEDICAL PRODUCTS MANUFACTURING, INC. | SONOMARK | 08/18/2006 |
| K963831 | MEDICAL RESOURCES | SHEATHES (NON-LATEX) | 02/10/1997 |
| K984639 | MEDISON AMERICA, INC. | THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER | 07/12/1999 |
| K992155 | MEDISON AMERICA, INC. | VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7 | 07/08/1999 |
| K093714 | MEDISON CO., LTD. | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | 12/10/2009 |
| K101829 | MEDISON CO., LTD. | THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM | 07/16/2010 |
| K103722 | MEDISON CO., LTD. | THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM | 01/05/2011 |
| K120156 | MEDLINE | PUREIMAGE ULTRASOUND TRANSMISSION GEL | 02/08/2012 |
| K191491 | MedXPress.Pro | EZ-Cover | 06/05/2020 |
| K040213 | MICROHELIX, INC. | MHLX7EC TRANSDUCER | 09/22/2004 |
| K992178 | N.M. BEALE CO. INC. | BALLOON FOR ULTRASONIC ENDOSCOPES | 05/12/2000 |
| K012522 | NATIONAL THERAPY PRODUCTS INC. | WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL | 10/18/2001 |
| K083877 | NEUSOFT MEDICAL SYSTEMS CO., LTD. | FLYING DIAGNOSTIC ULTRASOUND SYSTEM | 01/13/2009 |
| K982725 | OLYMPUS AMERICA, INC. | OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE | 10/23/1998 |
| K952892 | OLYMPUS AMERICA, INC. | OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) | 02/12/1996 |
| K982323 | OLYMPUS AMERICA, INC. | OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE | 12/11/1998 |
| K994106 | OLYMPUS AMERICA, INC. | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE | 06/02/2000 |
| K994103 | OLYMPUS AMERICA, INC. | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT | 09/05/2000 |
| K994069 | OLYMPUS AMERICA, INC. | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE | 06/02/2000 |
| K982610 | OLYMPUS OPTICAL, CO. | OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT) | 11/16/1998 |
| K041395 | PENTAX PRECISION INSTRUMENT CORP. | EG-3630UR | 06/09/2004 |
| K041397 | PENTAX PRECISION INSTRUMENT CORP. | EG-3830UT | 06/09/2004 |
| K041396 | PENTAX PRECISION INSTRUMENT CORP. | FG-36UX FIBER ULTRASOUND GASTROSCOPE | 06/09/2004 |
| K961974 | PENTAX PRECISION INSTRUMENT CORP. | FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE | 02/10/1997 |
| K081802 | PHILIPS ULTRASOUND, INC. | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | 07/11/2008 |
| K091804 | PHILIPS ULTRASOUND, INC. | CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS | 07/17/2009 |
| K022156 | PLEASURE LATEX PRODUCTS SDN. BHD. | LATEX ULTRASONIC PROBE COVER | 09/11/2003 |
| K971115 | PROTEK MEDICAL PRODUCTS, INC. | GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE | 06/13/1997 |
| K973958 | PROTEK MEDICAL PRODUCTS, INC. | GENERAL PURPOSE ATL NEEDLE GUIDE KIT | 01/22/1998 |
| K973362 | PROTEK MEDICAL PRODUCTS, INC. | NEEDLE GUIDE/GRID | 10/01/1997 |
| K971722 | PROTEK MEDICAL PRODUCTS, INC. | TRANS VAGINAL NEEDLE GUIDE | 07/10/1997 |
| K973622 | PROTEK MEDICAL PRODUCTS, INC. | TRANSDUCER POSITIONER | 11/26/1997 |
| K971397 | QUINTON, INC. | VIEWCATH 3-D CATHETER PULLBACK | 08/25/1997 |
| K963169 | RAPID-AID LTD./LTEE | RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL | 11/12/1996 |
| K092858 | SAFERSONIC MEDIZINPRODUKTE GMBH | SAFERSONIC SONOGRAPHY COVER | 11/10/2009 |
| K072541 | SENORX, INC. | SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM | 09/25/2007 |
| K101008 | SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY | 06/08/2010 |
| K990175 | SHEATHING TECHNOLOGIES, INC. | SHEATHES (NON-LATEX), STERILE | 04/21/1999 |
| K043425 | SHEATHING TECHNOLOGIES, INC. | SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) | 02/28/2005 |
| K153212 | Sheathing Technologies, Inc. | Sheathes Ultrasound Probe Covers | 03/04/2016 |
| K091828 | SHEATHING TECHNOLOGIES, INC. | SHEATHESISO ULTRASOUND TRANSDUCER COVER | 09/28/2009 |
| K091941 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM | 07/09/2009 |
| K072164 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-6 DIAGNOSTIC ULTRASOUND SYSTEM | 09/05/2007 |
| K092691 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM | 10/15/2009 |
| K101041 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM | 04/30/2010 |
| K102865 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM | 11/03/2010 |
| K090912 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900 | 04/15/2009 |
| K082224 | SHIMADZU MEDICAL SYSTEMS | DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC | 12/15/2008 |
| K071287 | SHIMADZU MEDICAL SYSTEMS | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO | 01/09/2008 |
| K071291 | SHIMADZU MEDICAL SYSTEMS | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | 01/09/2008 |
| K071289 | SHIMADZU MEDICAL SYSTEMS | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | 01/09/2008 |
| K072266 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM | 08/29/2007 |
| K072786 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON S2000 ULTRASOUND SYSTEM | 11/13/2007 |
| K060879 | SIEMENS MEDICAL SOLUTIONS USA, INC. | MODEL EC9-4 TRANSDUCER | 04/19/2006 |
| K121807 | SIEMENS MEDICAL SOLUTIONS USA, INC. | V5MS TRANSDUCER | 07/10/2012 |
| K052021 | SIEMENS MEDICAL SOLUTIONS USA, INC. | V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER | 08/17/2005 |
| K100204 | SMITH ASSOCIATES | SONALIS | 02/19/2010 |
| K092637 | SONOMED, INC. | PACSCAN PLUS, MODELS 300P AND 300AP | 09/24/2009 |
| K002856 | SONORA MEDICAL SYSTEMS | AT3C70 TRANSDUCER | 04/02/2001 |
| K030064 | SONOSITE,INC. | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY | 01/22/2003 |
| K101757 | SONOSITE,INC. | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM | 08/12/2010 |
| K983985 | SONOTECH, INC. | HYBRISONIC SHEATH | 02/25/1999 |
| K964658 | SONOTECH, INC. | OASIS | 02/14/1997 |
| K983691 | SONOTECH, INC. | SCANFLEX SOLID COUPLANT MEMBRANE | 05/05/1999 |
| K013170 | SONOTECH, INC. | SCANTAC MEMBRANE OR SCANTAC STRIP | 11/13/2001 |
| K961692 | SONOTECH, INC. | SONOSCAN | 08/22/1996 |
| K981028 | SONOTECH, INC. | ULTRA IMAGE AND ULTRA SCAN | 08/21/1998 |
| K962093 | SONOTECH, INC. | ULTRAMIX | 12/23/1996 |
| K984562 | SONOTECH, INC. | VIVOSONIC | 06/08/1999 |
| K170338 | Stroke2Prevent B.V. | A-View | 05/16/2017 |
| K101816 | SUMMIT DOPPLER SYSTEMS, INC. | STN PROBE | 08/19/2010 |
| K102041 | SUPERSONIC IMAGINE | AIXPLORER | 10/13/2010 |
| K963302 | TAYMAN MEDICAL, INC. | TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM | 02/06/1997 |
| K110020 | TERATECH CORP. | TERASON T3200 ULTRASOUND SYSTEM | 01/20/2011 |
| K040840 | TERATECH CORP. | TERATECH MODEL 10V5 SMART PROBE | 04/14/2004 |
| K010883 | TERATECH CORP. | TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE | 04/06/2001 |
| K043278 | TERATECH CORP. | TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES | 12/13/2004 |
| K014182 | TETRAD CORP. | TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS | 01/03/2002 |
| K013849 | TETRAD CORP. | TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS | 12/03/2001 |
| K002193 | TETRAD CORP. | TETRAD TC-C3-ACP | 05/04/2001 |
| K090465 | THE NEWMAN GROUP, LLC | DIGDOP ULTRASOUND SYSTEM | 04/08/2009 |
| K982733 | THE OLYMPUS OPTICAL CO. | OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE | 10/28/1998 |
| K001203 | THE OLYMPUS OPTICAL CO. | OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT | 05/26/2000 |
| K072826 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM | 10/24/2007 |
| K091295 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 | 05/15/2009 |
| K100067 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM | 01/28/2010 |
| K103629 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | PET-512MC TRANSESOPHAGEAL TRANSDUCER | 02/02/2011 |
| K970047 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | PHASED ARRAY TRANSDUCER - - PSK-20CT | 03/04/1997 |
| K972771 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | PHASED ARRAY TRANSDUCER - - PVF -375DT | 02/11/1998 |
| K964865 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | PVK-720ST ENDOCAVITARY TRANSDUCER | 03/10/1997 |
| K072918 | TOSHIBA MEDICAL SYSTEMS CORPORATION | MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 | 10/29/2007 |
| K103645 | TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM | 01/12/2011 |
| K013363 | TRANS VASCULAR INCORPORATED | CROSSPOINT TRANSACCESS CATHETER | 04/02/2002 |
| K031920 | TRANS VASCULAR INCORPORATED | CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 | 07/23/2003 |
| K101952 | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA | KONIX ULTRASOUND GEL | 05/27/2011 |
| K093462 | UltraSonix Medical Corporation | SONIX ULTRASOUND SCANNER | 11/20/2009 |
| K080970 | USHIFU DEVELOPMENT COMPANY, LLC | USHIFU STEPPER | 06/11/2008 |
| K031358 | VASCULAR CONTROL SYSTEMS, INC | TRANSVAGINAL DOPPLER PROBE | 05/09/2003 |
| K023024 | VASCULAR CONTROL SYSTEMS, INC | TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 | 09/26/2002 |
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