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 |
| K893833 | ACOUSTIC IMAGING | AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER | 09/11/1989 |
| K882737 | ACUSON CORP. | ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER | 09/08/1988 |
| K934915 | ACUSON CORP. | ACUSON MODEL 2001 | 10/21/1994 |
| K940285 | ACUSON CORP. | ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION | 04/29/1994 |
| K890055 | ACUSON CORP. | ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER | 05/16/1989 |
| 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 |
| K894054 | ADVANCED TECHNOLOGY LABORATORIES, INC. | 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER | 09/12/1989 |
| K840953 | ADVANCED TECHNOLOGY LABORATORIES, INC. | ACCESS SCANHEADSS | 06/15/1984 |
| K901329 | ADVANCED TECHNOLOGY LABORATORIES, INC. | CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM | 11/23/1990 |
| K011224 | ADVANCED TECHNOLOGY LABORATORIES, INC. | HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY | 05/04/2001 |
| K935009 | ADVANCED TECHNOLOGY LABORATORIES, INC. | PEGASUS | 10/11/1994 |
| K801972 | ADVANCED TECHNOLOGY LABORATORIES, INC. | TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX | 10/23/1980 |
| 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 |
| K941652 | ALOKA CO., LTD. | ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION | 10/21/1994 |
| 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 |
| K132687 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE 7 | 11/27/2013 |
| K123611 | ALPINION MEDICAL SYSTEMS CO., LTD | E-CUBE 7 | 12/21/2012 |
| 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 |
| K181617 | Alpinion Medical Systems Co., Ltd. | E-CUBE 8 | 10/11/2018 |
| K172732 | ALPINION MEDICAL SYSTEMS Co., Ltd. | E-CUBE 8 | 12/14/2017 |
| 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 |
| K810133 | ARS MAGNA | ULTRAPROBE | 06/09/1981 |
| K002003 | ATL ULTRASOUND, INC. | HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING | 07/13/2000 |
| K936067 | ATLANTIS DIAGNOSTICS INTL., INC. | ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM | 10/27/1995 |
| K182175 | Atys | TCD-X | 04/05/2019 |
| K012369 | ATYS MEDICAL | BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 | 08/10/2001 |
| K933916 | AUSONICS PTY LTD. | AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER | 10/03/1994 |
| 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 |
| K943863 | BIOPSYS MEDICAL, INC. | NEEDLE GUIDE | 12/29/1994 |
| 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 |
| K894163 | BIOSOUND, INC. | PHASE 2 TRANSCRANIAL PROBE | 09/12/1989 |
| K161960 | BK MEDICAL APS | bk2300 | 10/17/2016 |
| K180737 | BK Medical ApS | Ultrasound Scanner System bk2300 | 08/01/2018 |
| K151910 | BK MEDICAL APS | Ultrasound Scanner System BK2300 | 10/05/2015 |
| K152052 | BK MEDICAL APS | Ultrasound Scanner System bk2300 | 09/16/2015 |
| K143298 | BK MEDICAL APS | Ultrasound Scanner System bk2300 | 01/16/2015 |
| K173569 | BK Medical ApS | Ultrasound System 1300 | 02/23/2018 |
| 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 |
| K905198 | BRUEL & KJAER | DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 | 08/28/1991 |
| 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 |
| 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 |
| K180799 | Clarius Mobile Health Corp. | Clarius Ultrasound Scanner | 05/14/2018 |
| K192107 | Clarius Mobile Health Corp. | Clarius Ultrasound Scanner | 08/29/2019 |
| K172385 | Clarius Mobile Health Corp. | Clarius Ultrasound System | 09/14/2017 |
| K163138 | Clarius Mobile Health Corp. | Clarius Ultrasound System | 11/30/2016 |
| K051085 | COMPUMEDICS GERMANY GMGH | DOPPLER-BOX | 05/05/2005 |
| K840402 | D. E. HOKANSON, INC. | AUDIO BANDWIDTH ANALYZER | 05/09/1984 |
| K930458 | DANTEC MEDICAL, INC. | MULTI-DOP L | 02/03/1995 |
| K990517 | DIAGNOSTIC MEDICAL SYSTEMS | EXPLORER CVS TRANSCRANIAL DOPPLER | 08/01/2000 |
| K951998 | DIASONICS ULTRASOUND | DIASONICS MASTERS SERIES 5000 ULTRASOUND SCANNER | 03/27/1996 |
| K802979 | DIASONICS, INC. | DIASONICS SMALL PARTS SCANNER | 01/22/1981 |
| K781642 | DIASONICS, INC. | RA-I | 10/10/1978 |
| K041915 | DWL ELEKTRONISCHE SYSTEME GMBH | HEMO-DOP | 08/04/2004 |
| K812606 | ECHO LABORATORIES, INC. | SECTORTAC | 10/13/1981 |
| K926351 | ECHOCATH, INC. | COLORMARK(TM) VISUALIZATION SYSTEM | 09/16/1993 |
| 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 |
| 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 |
| 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 |
| K904359 | ELSCINT, INC. | ESI-3000 ULTRASOUND SYSTEM | 03/05/1991 |
| K935024 | ELSCINT, INC. | ESI-5000 | 06/12/1996 |
| K893042 | ENDOSONICS CORP. | CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM | 07/19/1989 |
| K802254 | ENGINEERING DYNAMICS CORP. | GENERAL ULTRASOUND EXAM. TABLE | 11/26/1980 |
| 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 |
| 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 |
| 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 |
| K140254 | EZONO AG | EZONO 4000 | 02/26/2014 |
| K160406 | FUJIFILM SonoSite, Inc. | FUJIFILM FC1 Ultrasound System | 03/16/2016 |
| K190476 | FUJIFILM SonoSite, Inc. | FUJIFILM Sonosite Vevo MD Imaging System | 03/15/2019 |
| K160674 | FUJIFILM SONOSITE, INC. | Fujifilm Sonosite Vevo MD Imaging System | 04/19/2016 |
| K180704 | FUJIFILM SonoSite, Inc. | SonoSite iViz Ultrasound System | 04/13/2018 |
| K162288 | FUJIFILM SONOSITE, INC. | SonoSite iViz Ultrasound System | 09/08/2016 |
| K183235 | FUJIFILM SonoSite, Inc. | SonoSite SII Ultrasound System | 02/07/2019 |
| K160734 | FUJIFILM SonoSite, Inc. | SonoSite SII Ultrasound System | 04/05/2016 |
| 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 |
| K130173 | FUJIFILM SONOSITE,INC. | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | 03/25/2013 |
| K133134 | FUJIFILM SONOSITE,INC. | X-PORTE ULTRASOUND SYSTEM | 11/04/2013 |
| K033209 | FUKUDA DENSHI USA, INC. | FUKUDA DENSHI MODEL FF SONIC UF-750XT | 10/31/2003 |
| K050363 | FUKUDA DENSHI USA, INC. | FUKUDA DENSHI MODEL UF-850XTD | 02/17/2005 |
| K082656 | FUKUDA DENSHI USA, INC. | MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT | 09/30/2008 |
| K092271 | GE HEALTHCARE | GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 | 11/17/2009 |
| K113690 | GE HEALTHCARE | GE LOGIQ I, LOGIQ E AND VIVID E | 12/29/2011 |
| K101878 | GE HEALTHCARE | GE LOGIQ P5 MODEL H44662LD | 08/31/2010 |
| K101874 | GE HEALTHCARE | GE LOGIQ P6/P6 PRO | 10/05/2010 |
| K133533 | GE HEALTHCARE | LOGIQ E | 02/12/2014 |
| K173555 | GE Healthcare | LOGIQ E10 | 12/20/2017 |
| K110943 | GE HEALTHCARE | LOGIQ E9 | 07/22/2011 |
| K142160 | GE HEALTHCARE | LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM | 10/10/2014 |
| K123564 | GE HEALTHCARE | LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM | 12/18/2012 |
| K133034 | GE HEALTHCARE | LOGIQ F SERIES | 01/31/2014 |
| K112371 | GE HEALTHCARE | LOGIQ P3 | 09/27/2011 |
| K163596 | GE HEALTHCARE | LOGIQ P9 and LOGIQ P7 | 02/10/2017 |
| K161047 | GE Healthcare | LOGIQ P9 and LOGIQ P7 | 05/05/2016 |
| K143452 | GE HEALTHCARE | LOGIQ P9, LOGIQ P7 | 01/29/2015 |
| K181783 | GE Healthcare | LOGIQ P9; LOGIQ P7 | 09/20/2018 |
| K160182 | GE Healthcare | LOGIQ S7 Expert | 02/26/2016 |
| K141261 | GE HEALTHCARE | LOGIQ S7 EXPERT, LOGIQ S7 PRO | 06/05/2014 |
| K122114 | GE HEALTHCARE | LOGIQ S7 EXPERT, LOGIQ S7 PRO | 10/03/2012 |
| K152195 | GE Healthcare | LOGIQ S8 | 09/29/2015 |
| K170445 | GE Healthcare | LOGIQ S8 | 04/11/2017 |
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| K141720 | UNITED IMAGING SYSTEMS (BEIJING) CO., LTD. | iuStar300 Medical Ultrasound Diagnostic System | 07/23/2015 |
| K971790 | UROMETRICS, INC. | KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) | 12/17/1997 |
| K043139 | USCOM, LTD. | USCOM 1A | 02/15/2005 |
| K173810 | Ventripoint Diagnostics, Ltd. | Ventripoint Medical System Plus (VMS+) | 05/14/2018 |
| K150628 | VENTRIPOINT, INC. | VentriPoint Medical System | 05/22/2015 |
| K140153 | VENTRIPOINT, INC. | VENTRIPOINT MEDICAL SYSTEM | 03/06/2014 |
| K170859 | Viasonix Ltd. | Dolphin/IQ and Dolphin/4D | 11/14/2017 |
| K191023 | Viasonix Ltd. | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | 05/16/2019 |
| K060421 | VIASYS HEALTHCARE, INC. | SONARA; SONARA/TEK | 11/03/2006 |
| K053648 | VIASYS NEURO CARE | PIONEER TC8080, COMPANION III | 01/24/2006 |
| K982498 | VOLUMETRICS MEDICAL IMAGING, INC. | DIAGNOSTIC ULTRASOUND SYSTEM | 08/07/1998 |
| K173265 | WinProbe Corporation | UltraVision 2 Diagnostic Ultrasound System | 11/07/2017 |
| K102104 | WIPRO GE HEALTHCARE PRIVATE, LTD. | GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | 10/01/2010 |
| K183041 | Wuhan Zoncare Bio-medical Electronics Co., Ltd | Full Digital Colour Doppler Ultrasonic Diagnostic System | 07/10/2019 |
| K101091 | ZONARE MEDICAL SYSTEMS, INC. | Z.ONE ULTRA ULTRASOUND SYSTEM | 06/25/2010 |
| K082326 | ZONARE MEDICAL SYSTEMS, INC. | ZONARE ULTRA ULTRASOUND SYSTEM | 10/08/2008 |
| K150249 | ZONARE MEDICAL SYSTEMS, INC. | ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System | 03/04/2015 |
| K141641 | ZONARE MEDICAL SYSTEMS, INC. | ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM | 07/18/2014 |
| K151175 | ZONARE MEDICAL SYSTEMS, INC. | ZONARE ZS3 Diagnostic Ultrasound System | 05/15/2015 |
| K120703 | ZONARE MEDICAL SYSTEMS, INC. | ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM | 04/13/2012 |
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