|
Device |
system, imaging, pulsed doppler, ultrasonic |
Product Code | IYN |
Regulation Number |
892.1550
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACCUTOME, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACO HEALTHCARE CO,. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACO HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED INSTRUMENTATIONS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED INSTRUMENTATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALOKA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALPINION MEDICAL SYSTEMS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
ALPINION MEDICAL SYSTEMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
15
|
ATYS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B-K MEDICAL APS |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BARD ACCESS SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING KONTED MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BENQ MEDICAL TECHNOLOGY CORPATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIONET CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BK MEDICAL APS |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
BRONCUS TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BUTTERFLY NETWORK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANON MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
CARESTREAM HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANG GUNG MEDICAL SUPPLIES & EQUIPMENT CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHISON MEDICAL IMAGING CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
CHISON MEDICAL TECHNOLOGIES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
CLARIUS MOBILE HEALTH CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
COMPAL ELECTRONICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CRYSTALLINE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
E-SCOPICS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ECHONOUS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EDAN INSTRUMENTS INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EDAN INSTRUMENTS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EDAN INSTRUMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ESAOTE EUROPE B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ESAOTE S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ESAOTE S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
ESAOTE, S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
ESCALON MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACT IMAGING INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACT IMAGING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXO IMAGING INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EZONO AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM HEALTHCARE AMERICAS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM HEALTHCARE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM SONOSITE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FUJIFILM SONOSITE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
FUJIFILM SONOSITE,INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
GE HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
52
|
1. K092271 GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, M ...
|
2. K101236 VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYST ...
|
3. K101874 GE LOGIQ P6/P6 PRO
|
4. K101878 GE LOGIQ P5 MODEL H44662LD
|
5. K103649 VOLUSON S6, VOLUSON S8
|
6. K110943 LOGIQ E9
|
7. K111582 LOGIQ S8
|
8. K112122 VENUE 40
|
9. K112213 VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOU ...
|
10. K112371 LOGIQ P3
|
11. K113690 GE LOGIQ I, LOGIQ E AND VIVID E
|
12. K120741 VOLUSON S6, VOLUSON S8
|
13. K122114 LOGIQ S7 EXPERT, LOGIQ S7 PRO
|
14. K122327 VOLUSON E6/E8/E8EXPERT/E10
|
15. K122387 VOLUSON P6, VOLUSON P8
|
16. K123564 LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
|
17. K131267 VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E1 ...
|
18. K131527 LOGIQ S8
|
19. K131937 VOLUSON I/E
|
20. K132913 VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDIT ...
|
21. K133034 LOGIQ F SERIES
|
22. K133431 VENUE 50
|
23. K133533 LOGIQ E
|
24. K141067 VIVID T8/VIVID T8 PRO
|
25. K141261 LOGIQ S7 EXPERT, LOGIQ S7 PRO
|
26. K141639 VOLUSON S6, VOLUSON S8
|
27. K141675 VOLUSON P6, VOLUSON P8
|
28. K141768 LOGIQ V5/LOGIQ V3
|
29. K142160 LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
|
30. K142472 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic U ...
|
31. K143452 LOGIQ P9, LOGIQ P7
|
32. K152195 LOGIQ S8
|
33. K152567 Voluson E6, Voluson E8, Voluson E10 Diagnostic Ult ...
|
34. K160162 Voluson P6, Voluson P8
|
35. K160182 LOGIQ S7 Expert
|
36. K160184 Voluson S6, Voluson S8, Voluson S10
|
37. K161047 LOGIQ P9 and LOGIQ P7
|
38. K162269 Voluson E6, Voluson E8, Voluson E10
|
39. K163596 LOGIQ P9 and LOGIQ P7
|
40. K170445 LOGIQ S8
|
41. K172342 Voluson E6, Voluson E8, Voluson E10
|
42. K173555 LOGIQ E10
|
43. K180374 Voluson S8/ Voluson S10/ Voluson S10 Expert
|
44. K180535 Voluson P6 and Voluson P8
|
45. K181783 LOGIQ P9; LOGIQ P7
|
46. K181985 Voluson E6, Voluson E8, Voluson E10
|
47. K192159 Voluson E6, Voluson E8, Voluson E10
|
48. K201768 Voluson E10
|
49. K211488 LOGIQ E10
|
50. K211524 LOGIQ E10s, LOGIQ Fortis
|
51. K213642 Voluson S6, Voluson S8, Voluson S8t, Voluson S10, ...
|
52. K213689 Voluson P6, Voluson P8
|
GE MEDICAL SYSTEM ISRAEL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE MEDICAL SYSTEM ULTRASOUND AND PRIMARY CARE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GE MEDICAL SYSTEMS CHINA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GE MEDICAL SYSTEMS ISRAEL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTIC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS ULTRASOUND AND |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTIC, |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
17
|
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS, |
|
SUBSTANTIALLY EQUIVALENT
|
22
|
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOTICS, L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSYEMS ULTRASOUND & PRIMARY CARE DIAGN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE VINGMED ULTRASOUND AS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GUANGDONG YOUKEY MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HEALCERION CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HEALCERION CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HITACHI ALOKA MEDICAL AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HITACHI ALOKA MEDICAL, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HITACHI HEALTHCARE AMERICAS |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
HITACHI HEALTHCARE AMERICAS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HITACHI MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HITACHI, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HITACHI, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMACOR INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMACOR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMSONIC MEDICAL CHINA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTERSON CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KOELIS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KOLO MEDICAL (SUZHOU) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KONICA MINOLTA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KONICA MINOLTA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LELTEK INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LIFE-TECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LINKQUEST INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDISON CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MEDISONO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDISONO, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
METRITRACK LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NATIONAL TAIWAN UNIVERSITY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NAVIGANT CONSULTING - ON BEHALF OF ESAOTE S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEURAL ANALYTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEUROCHAOS SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVASIGNAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NU VUE THERAPEUTICS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS MEDICAL SYSTEMS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OLYMPUS MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PANASONIC HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PENRITH CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
PHILIPS HEALTHCARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHILIPS ULTRASOUND |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHILIPS ULTRASOUND LLC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
PHILIPS ULTRASOUND, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
16
|
PHYSIOSONICS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
QISDA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
RIMED LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAMSUNG MEDISON CO, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAMSUNG MEDISON CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
20
|
SAMSUNG MEDISON CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
37
|
SASET (CHENGDU) INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SENO MEDICAL INSTRUMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD (SIUI) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI) |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN DELICATE ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
47
|
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO.LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS HEALTHINEERS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS INC. ULTRASOUND GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
27
|
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIEMENS MEDICAL SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SIEMENS MEDICAL SOLUTIONS, INC., ULTRASOUND DIVISION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS, USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS, USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SIEMENS MEDICAL SOLUTIONS, USA, INC. ULTRASOUND GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNOSTICS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNOSTICS PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SILICON VALLY MEDICAL INSTRUMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SONIO |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SONOSCANNER |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SONOSCANNER SARL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SONOSCAPE COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
16
|
SONOSCAPE MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
18
|
SONOSITE,INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SUPERSONIC IMAGINE |
|
SUBSTANTIALLY EQUIVALENT
|
14
|
SYNOVIS MICRO COMPANIES ALLIANCE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEMED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TERATECH CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
TERATECH CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TISSUE DIFFERENTIATION INTELLIGENCE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
TOSHIBA MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
16
|
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOYOTA TSUSHO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTRASONIX MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
UNITED IMAGING SYSTEMS (BEIJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENTRIPOINT DIAGNOSTICS, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENTRIPOINT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VIASONIX LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VINNO TECHNOLOGY (SUZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VINNO TECHNOLOGY (SUZHOU) CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VINNO TECHNOLOGY (SUZHOU) CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WINPROBE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WIPRO GE HEALTHCARE PRIVATE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WUHAN ZONCARE BIO-MEDICAL ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZONARE MEDICAL SYSTEMS, INC. |
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SUBSTANTIALLY EQUIVALENT
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5
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Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
B-K Medical A/S |
II |
Jan-25-2024 |
2 |
B-K Medical A/S |
II |
Aug-03-2016 |
3 |
Bard Access Systems |
II |
Jul-11-2011 |
4 |
Boston Scientific Corporation |
II |
Apr-22-2014 |
5 |
Butterfly Network, Inc. |
II |
Mar-17-2020 |
6 |
Butterfly Network, Inc. |
II |
Mar-17-2020 |
7 |
Canon Medical System, USA, INC. |
II |
Nov-08-2022 |
8 |
Cardinal Health, Inc |
II |
Apr-07-2009 |
9 |
Carestream Health Inc |
II |
Jan-19-2017 |
10 |
Carestream Health Inc |
II |
Jul-18-2016 |
11 |
ESAOTE S.P.A |
II |
Sep-30-2020 |
12 |
ESAOTE S.P.A. |
II |
Oct-23-2018 |
13 |
ESAOTE S.P.A. |
II |
Mar-20-2018 |
14 |
FujiFilm Healthcare Americas Corporation |
II |
Nov-02-2021 |
15 |
FujiFilm Healthcare Americas Corporation |
II |
Nov-02-2021 |
16 |
GE HEALTHCARE AUSTRIA GMBH & CO |
II |
Jan-30-2024 |
17 |
GE Healthcare, LLC |
II |
Jul-12-2019 |
18 |
GE Healthcare, LLC |
II |
Jun-18-2019 |
19 |
GE Healthcare, LLC |
II |
Jan-30-2019 |
20 |
GE Healthcare, LLC |
II |
Dec-07-2018 |
21 |
GE Healthcare, LLC |
II |
Apr-11-2017 |
22 |
GE Healthcare, LLC |
II |
Apr-23-2014 |
23 |
GE Healthcare, LLC |
II |
Aug-09-2013 |
24 |
GE Healthcare, LLC |
II |
Aug-01-2013 |
25 |
GE Healthcare, LLC |
II |
Jul-31-2013 |
26 |
GE Healthcare, LLC |
II |
Apr-11-2013 |
27 |
GE Healthcare, LLC |
II |
Feb-23-2012 |
28 |
GE Healthcare, LLC |
II |
Jan-21-2012 |
29 |
GE Healthcare, LLC |
II |
Jan-11-2012 |
30 |
GE MEDICAL SYSTEMS, ISRAEL LTD. |
II |
Sep-29-2023 |
31 |
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL |
II |
Sep-06-2018 |
32 |
GE Medical Systems, LLC |
II |
Dec-22-2022 |
33 |
GE Vingmed Ultrasound As |
II |
Jul-10-2023 |
34 |
Hitachi Aloka Medical, Ltd. |
II |
Mar-29-2017 |
35 |
Hitachi Healthcare Americas Corporation |
II |
Aug-16-2021 |
36 |
Hitachi Medical Systems America Inc |
II |
Mar-19-2021 |
37 |
Hitachi Medical Systems America Inc |
II |
May-12-2017 |
38 |
Hitachi Medical Systems America Inc |
II |
Jun-08-2011 |
39 |
Konica Minolta Medical Imaging USA, Inc. |
II |
Mar-27-2018 |
40 |
Konica Minolta, Inc. |
II |
Jul-26-2017 |
41 |
Mindray DS USA, Inc. dba Mindray North America |
II |
Feb-05-2020 |
42 |
NeuroLogica Corporation |
II |
Aug-14-2019 |
43 |
NovaSignal Corp. |
II |
Feb-01-2023 |
44 |
Olympus Corporation of the Americas |
II |
Nov-27-2020 |
45 |
Olympus Corporation of the Americas |
II |
Mar-12-2019 |
46 |
Philips Medical Systems Nederlands |
II |
Apr-25-2011 |
47 |
Philips Medical Systems North America Inc. |
II |
Mar-20-2014 |
48 |
Philips Medical Systems North America Inc. |
II |
Nov-20-2013 |
49 |
Philips Ultrasound Inc |
II |
Oct-16-2021 |
50 |
Philips Ultrasound Inc |
II |
Oct-07-2021 |
51 |
Philips Ultrasound Inc |
II |
Aug-16-2021 |
52 |
Philips Ultrasound Inc |
II |
Feb-03-2021 |
53 |
Philips Ultrasound Inc |
II |
Feb-02-2021 |
54 |
Philips Ultrasound Inc |
II |
Jan-14-2021 |
55 |
Philips Ultrasound Inc |
II |
Aug-06-2019 |
56 |
Philips Ultrasound, Inc. |
II |
Nov-09-2023 |
57 |
Philips Ultrasound, Inc. |
II |
Apr-13-2016 |
58 |
Philips Ultrasound, Inc. |
II |
Jan-06-2016 |
59 |
Philips Ultrasound, Inc. |
II |
May-19-2015 |
60 |
Philips Ultrasound, Inc. |
II |
May-05-2015 |
61 |
Philips Ultrasound, Inc. |
II |
Dec-16-2014 |
62 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-19-2024 |
63 |
Siemens Medical Solutions USA, Inc. |
II |
Sep-13-2023 |
64 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-27-2022 |
65 |
Siemens Medical Solutions USA, Inc. |
II |
Mar-11-2022 |
66 |
Siemens Medical Solutions USA, Inc. |
II |
Feb-03-2022 |
67 |
Siemens Medical Solutions USA, Inc. |
II |
Sep-14-2021 |
68 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-01-2021 |
69 |
Siemens Medical Solutions USA, Inc. |
II |
Aug-22-2019 |
70 |
Siemens Medical Solutions USA, Inc. |
II |
Mar-26-2018 |
71 |
Siemens Medical Solutions USA, Inc. |
II |
Mar-15-2018 |
72 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-24-2017 |
73 |
Siemens Medical Solutions USA, Inc. |
II |
Nov-28-2016 |
74 |
Siemens Medical Solutions USA, Inc. |
II |
May-02-2016 |
75 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-27-2016 |
76 |
Siemens Medical Solutions USA, Inc. |
II |
Oct-30-2015 |
77 |
Siemens Medical Solutions USA, Inc. |
II |
Sep-17-2015 |
78 |
Siemens Medical Solutions USA, Inc. |
II |
Aug-05-2015 |
79 |
Siemens Medical Solutions USA, Inc. |
II |
Jul-30-2015 |
80 |
Siemens Medical Solutions USA, Inc. |
II |
Jul-29-2015 |
81 |
Siemens Medical Solutions USA, Inc. |
II |
Jul-02-2015 |
82 |
Siemens Medical Solutions USA, Inc. |
II |
May-06-2015 |
83 |
Siemens Medical Solutions USA, Inc. |
II |
Feb-05-2015 |
84 |
Siemens Medical Solutions USA, Inc. |
II |
Jul-01-2014 |
85 |
Siemens Medical Solutions USA, Inc. |
II |
May-28-2014 |
86 |
Siemens Medical Solutions USA, Inc. |
II |
May-28-2014 |
87 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-24-2014 |
88 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-03-2014 |
89 |
Siemens Medical Solutions USA, Inc. |
II |
Jan-24-2014 |
90 |
Siemens Medical Solutions USA, Inc. |
II |
Jan-24-2014 |
91 |
Siemens Medical Solutions USA, Inc. |
II |
Oct-23-2013 |
92 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-10-2013 |
93 |
Siemens Medical Solutions USA, Inc. |
II |
May-16-2012 |
94 |
Siemens Medical Solutions USA, Inc. |
II |
May-06-2011 |
95 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-29-2011 |
96 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-25-2011 |
97 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-22-2011 |
98 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-08-2011 |
99 |
Siemens Medical Solutions USA, Inc. |
II |
Mar-30-2011 |
100 |
Siemens Medical Solutions USA, Inc. |
II |
Mar-28-2011 |
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