|
Device |
system, imaging, pulsed echo, ultrasonic |
Product Code | IYO |
Regulation Number |
892.1560
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACCUTOME, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ADECHO TECH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED INSTRUMENTATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALOKA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPINION MEDICAL SYSTEMS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANALOGIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARCSCAN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARDENT SOUND, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVANTSONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
B-K MEDICAL APS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BARD ACCESS SYSTEMS, INC, (C.R. BARD, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BARD ACCESS SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BARD ACCESS SYSTEMS, INC. (C.R. BARD, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIIM ULTRASOUND AS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOBOT SURGICAL PTE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BOSTON SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BUTTERFLY NETWORK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
C.R. BARD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARENOSO TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESONO TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CERACARTA SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CIVCO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CIVCO MEDICAL INSTRUMENTS CO INC DBA CIVCO MEDICAL SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLEAR GUIDE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONTEC MEDICAL SYSTEMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONTOUR FABRICATORS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DBMEDX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DELPHINUS MEDICAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DELPHINUS MEDICAL TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DGH TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DOLPHIN MEDICAL IMAGING, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ECHOLIGHT S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ECHONOUS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ECHOSENS |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
EDAN INSTRUMENTS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDAN INSTRUMENTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDAN INSTRUMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
EDGECARE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EIELING TECHNOLOGY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELLEX MEDICAL PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELLEX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EMAGINE SOLUTIONS TECHNOLOGY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ESAOTE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACT IMAGING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACT IMAGING INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FCU CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE MEDICAL SYSTEM ISRAEL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS CHINA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE VINGMED ULTRASOUND AS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HALO MEDICAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALCERION CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMACOR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INFRAREDX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNEROPTIC TECHNOLOGY, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ISONO HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KONICA MINOLTA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LEIKER REGULATORY & QUALITY CONSULTING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE-TECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIGHTMED USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIGHTMED USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LILIUM OTSUKA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAUI IMAGING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MCUBE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
MEDA CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDA CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDA CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDNOVEL TECHNOLOGY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
METRITRACK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MOBISANTE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NAVIFUS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OPKO INSTRUMENTATION, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OREON TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PANASONIC HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS VOLCANO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QISDA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QT IMAGING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QT ULTRASOUND LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
QT ULTRASOUND, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUANTEL MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
QUANTEL MEDICAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
QUANTEL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RIVANNA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SAMSUNG MEDISON CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SASET (CHENGDU) INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNOSTICS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNOSTICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNOSTICS PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOMA ACCESS SYSTEMS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SONAVEX, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SONIC INCYTES |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SONIVATE MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SONOMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SONOSCAPE COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SONOSITE,INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ST. JUDE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU LISCHKA MEDTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIHAO MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEMED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
THD SPA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
THE PROMETHEUS GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRACTUS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTRASONIX MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTRASOUND BIOTECHNOLOGY (SHANGHAI) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTRASOUND MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VAVE HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERATHON INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VITACON MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VOLCANO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
14
|
WEIPENG (SUZHOU) MEDICAL DEVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WINPROBE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
XUZHOU KAIXIN ELECTRONIC INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Becton Dickinson & Company |
II |
Nov-23-2019 |
2 |
Civco Medical Instruments Co. Inc. |
II |
Dec-20-2021 |
3 |
Civco Medical Instruments Inc |
II |
Jul-06-2012 |
4 |
ECOLAB INC |
III |
Jul-13-2018 |
5 |
GE Healthcare, LLC |
II |
Jan-24-2022 |
6 |
GE Healthcare, LLC |
II |
Nov-21-2013 |
7 |
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL |
II |
Sep-06-2018 |
8 |
GE Medical Systems, LLC |
II |
Dec-16-2009 |
9 |
GE Medical Systems, LLC |
II |
Nov-09-2009 |
10 |
Parker Laboratories, Inc. |
II |
May-09-2018 |
11 |
Parker Laboratories, Inc. |
II |
Oct-29-2014 |
12 |
Philips Ultrasound Inc |
II |
Sep-17-2021 |
13 |
Siemens Medical Solutions USA, Inc. |
II |
May-05-2015 |
14 |
Siemens Medical Solutions USA, Inc. |
II |
Feb-07-2015 |
15 |
Siemens Medical Solutions USA, Inc. |
II |
Mar-09-2013 |
16 |
Siemens Medical Solutions USA, Inc. |
II |
May-30-2012 |
17 |
Siemens Medical Solutions USA, Inc. |
II |
May-06-2011 |
18 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-25-2011 |
19 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-04-2011 |
20 |
Siemens Medical Solutions USA, Inc. |
II |
Feb-01-2011 |
21 |
Siemens Medical Solutions USA, Inc., Mountain View, CA |
II |
Mar-28-2011 |
22 |
Soma Access Systems LLC |
II |
Dec-16-2014 |
23 |
SonoSite, Inc. |
II |
Oct-18-2013 |
24 |
Sonogage Inc |
II |
Sep-16-2013 |
25 |
Sonosite, Inc. |
II |
Aug-09-2010 |
26 |
Toshiba American Medical Systems Inc |
II |
Aug-10-2011 |
27 |
Toshiba American Medical Systems Inc |
II |
Mar-03-2011 |
28 |
Toshiba American Medical Systems Inc |
II |
Jul-06-2010 |
29 |
Toshiba American Medical Systems Inc |
II |
Mar-11-2010 |
30 |
Verathon, Inc. |
II |
Mar-10-2016 |
31 |
Verathon, Inc. |
II |
Oct-04-2010 |
32 |
Verathon, Inc. |
II |
Sep-17-2009 |
33 |
Volcano Corp |
III |
Apr-09-2022 |
34 |
Volcano Corp |
II |
Jul-08-2015 |
35 |
Volcano Corporation |
II |
Dec-12-2019 |
36 |
Volcano Corporation |
II |
May-17-2018 |
37 |
Volcano Corporation |
II |
Jul-20-2015 |
38 |
Volcano Corporation |
II |
Sep-10-2012 |
39 |
Volcano Corporation |
II |
Feb-07-2012 |
40 |
Volcano Corporation |
II |
Nov-01-2010 |
|
|
|
|