|
Device |
system, x-ray, tomography, computed |
Product Code | JAK |
Regulation Number |
892.1750
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
4DMEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
4DX LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACTIVIEWS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
AIDOC MEDICAL, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANALOGIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ARINETA LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BRAINLAB AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BUNKERHILL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANON MEDICAL INFORMATICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANON MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
18
|
CANON MEDICAL SYSTEMS USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CAS INNOVATIONS GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CASCINATION AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CEFLA S.C. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CLEAR GUIDE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
COVIDIEN LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CURVEBEAM, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
E-WOO TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDDA TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLUIDDA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FMI MEDICAL SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FUJIFILM HEALTHCARE AMERICAS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FUJIFILM HEALTHCARE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE HANGWEI MEDICAL SYSTEM CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE HANGWEI MEDICAL SYSTEMS CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE HANGWEI MEDICAL SYSTEMS, CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE HEALTHCARE JAPAN CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
GE MEDICAL SYSTEMS SCS |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
GE MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS, L.L.C. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
GE MEDICAL SYSTEMS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
GE MEDICAL SYSTEMS,LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GEF MEDICAL SYSTEMS SCS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENERAL ELECTRIC CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU DEEPWISE & LEAGUE OF PHD TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HITACHI HEALTHCARE AMERICAS |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
HITACHI HEALTHCARE AMERICAS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
ICAD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMACTIS, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMAGING BIOMETRICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMBIO LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMBIO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMRIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ISYS MEDIZINTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
KGT INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MASMEC SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIC VISION IMAGING SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEVIS MEDICAL SOLUTIONS AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOBIUS IMAGING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOBIUS IMAGING, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NANO-X AI LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOXAI LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOCOIL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUROLOGICA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEUROLOGICA CORPORATION, |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEUROLOGICA CORPORATION, A SUBSIDIARY OF SAMSUNG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUROLOGICA CORPORATION, A SUBSIDIARY OF SAMSUNG ELECTRONICS |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
NEUWAVE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
P-CURE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARITIC INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERFINT HEALTHCARE PVT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHILIPS HEALTHCARE (CLEVELAND) |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PHILIPS HEALTHCARE (SUZHOU) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS HEALTHCARE (SUZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
PHILIPS MEDICAL SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PHILIPS MEDICAL SYSTEMS NEDERLAND, B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS ULTRASOUND INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS ULTRASOUND LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS ULTRASOUND, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILLIPS MEDICAL SYSTEMS (CLEVELAND) INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PLANMED OY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PULMONX CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QI IMAGING, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QR S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUANTUM SURGICAL SAS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RIGHT DOSE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGAI UNITED IMAGING HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
SIEMENS AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS AG, MEDICAL SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SIEMENS HEALTHCARE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SIEMENS MEDICAL SOLUTIONS U.S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
65
|
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SIEMENS MEDICAL SOLUTIONS, USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS, USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOULTIONS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
SUPERDIMENSION INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SUPERDIMENSION, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
THIRONA BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THIRONA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOSHIBA MEDICAL SYSTEMS COROPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOSHIBA MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
27
|
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VARIAN MEDICAL SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VARIAN MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VATECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VERAN MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
VIDA DIAGNOSTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITAL IMAGES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITAL IMAGES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
XACT ROBOTICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
XACT ROBOTICS, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XORAN TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZEBRA MEDICAL VISION LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZETTA MEDICAL TECHNOLOGIES, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Bayer Medical Care, Inc. |
II |
Aug-31-2018 |
2 |
Brainlab AG |
II |
Feb-03-2018 |
3 |
Canon Medical System, USA, INC. |
II |
Dec-09-2020 |
4 |
Canon Medical System, USA, INC. |
II |
Apr-10-2020 |
5 |
Carestream Health, Inc. |
II |
Apr-23-2019 |
6 |
Covidien, LLC |
II |
Jun-26-2023 |
7 |
FUJIFILM Healthcare Americas Corporation |
II |
Sep-16-2022 |
8 |
GE Healthcare |
II |
Sep-21-2015 |
9 |
GE Healthcare |
II |
May-15-2015 |
10 |
GE Healthcare |
II |
Jan-26-2015 |
11 |
GE Healthcare |
II |
Jan-15-2015 |
12 |
GE Healthcare Japan Corporation |
II |
Aug-17-2018 |
13 |
GE Healthcare, LLC |
II |
Apr-05-2022 |
14 |
GE Healthcare, LLC |
II |
Nov-24-2021 |
15 |
GE Healthcare, LLC |
II |
Jul-08-2021 |
16 |
GE Healthcare, LLC |
II |
Jul-08-2021 |
17 |
GE Healthcare, LLC |
II |
Jun-25-2021 |
18 |
GE Healthcare, LLC |
II |
Feb-17-2021 |
19 |
GE Healthcare, LLC |
II |
Dec-22-2020 |
20 |
GE Healthcare, LLC |
II |
Oct-29-2020 |
21 |
GE Healthcare, LLC |
II |
Jul-12-2019 |
22 |
GE Healthcare, LLC |
II |
May-03-2019 |
23 |
GE Healthcare, LLC |
II |
Feb-06-2019 |
24 |
GE Healthcare, LLC |
II |
Jul-31-2018 |
25 |
GE Healthcare, LLC |
II |
Jun-12-2017 |
26 |
GE Healthcare, LLC |
II |
Jun-06-2016 |
27 |
GE Healthcare, LLC |
II |
Mar-20-2014 |
28 |
GE Healthcare, LLC |
II |
Mar-06-2014 |
29 |
GE Healthcare, LLC |
II |
Jan-27-2014 |
30 |
GE Healthcare, LLC |
II |
Oct-17-2013 |
31 |
GE Healthcare, LLC |
II |
Aug-09-2013 |
32 |
GE Healthcare, LLC |
II |
Jun-18-2013 |
33 |
GE Healthcare, LLC |
II |
Apr-29-2013 |
34 |
GE Healthcare, LLC |
II |
Mar-01-2013 |
35 |
GE Healthcare, LLC |
II |
May-19-2011 |
36 |
GE Healthcare, LLC |
II |
Mar-01-2011 |
37 |
GE Healthcare, LLC |
II |
Feb-07-2011 |
38 |
GE Healthcare, LLC |
II |
Jan-04-2011 |
39 |
GE Healthcare, LLC |
II |
Nov-15-2010 |
40 |
GE Medical Systems, LLC |
II |
Apr-29-2016 |
41 |
GE Medical Systems, LLC |
II |
Mar-04-2016 |
42 |
GE Medical Systems, LLC |
II |
Dec-10-2015 |
43 |
GE Medical Systems, LLC |
II |
Dec-17-2010 |
44 |
GE Medical Systems, LLC |
II |
Jan-21-2010 |
45 |
GE Medical Systems, LLC |
II |
Sep-25-2009 |
46 |
GE Medical Systems, LLC |
II |
Sep-18-2009 |
47 |
GE Medical Systems, LLC |
II |
Aug-13-2009 |
48 |
Ge Healthcare |
II |
Feb-02-2010 |
49 |
Hitachi Medical Systems America Inc |
II |
Nov-01-2019 |
50 |
Hitachi Medical Systems America Inc |
II |
Aug-17-2018 |
51 |
Hitachi Medical Systems America Inc |
II |
Aug-11-2016 |
52 |
Hitachi Medical Systems America Inc |
II |
Jul-19-2012 |
53 |
Hitachi Medical Systems America Inc |
II |
Jul-07-2009 |
54 |
Hitachi Medical Systems America Inc |
II |
Jan-08-2009 |
55 |
Imactis |
II |
Mar-16-2021 |
56 |
Imactis |
II |
Sep-15-2020 |
57 |
Imactis |
II |
Jan-22-2020 |
58 |
Imaging Sciences International, LLC |
II |
Aug-12-2011 |
59 |
Imaging Sciences International, LLC |
II |
Dec-17-2009 |
60 |
Mobius Imaging, LLC |
II |
Jan-17-2023 |
61 |
Mobius Imaging, LLC |
II |
Dec-06-2022 |
62 |
Mobius Imaging, LLC |
II |
Sep-14-2018 |
63 |
Mobius Imaging, LLC |
II |
Feb-24-2018 |
64 |
Mobius Imaging, LLC |
II |
Jan-27-2015 |
65 |
NEUSOFT MEDICAL SYSTEMS IMP & EX |
II |
Feb-05-2019 |
66 |
Neuisys, LLC |
II |
Aug-19-2010 |
67 |
NeuroLogica Corporation |
II |
Jul-03-2023 |
68 |
NeuroLogica Corporation |
II |
Aug-07-2020 |
69 |
Neusoft Medical System Co |
II |
Jun-16-2015 |
70 |
Neusoft Medical Systems Co., Ltd. |
II |
May-21-2019 |
71 |
Neusoft Medical Systems Co., Ltd. |
II |
Aug-28-2017 |
72 |
Neusoft Medical Systems Co., Ltd. |
II |
Dec-23-2016 |
73 |
Neusoft Medical Systems Co., Ltd. |
II |
May-11-2016 |
74 |
Northridge Tri-Modality Imaging, |
II |
Sep-30-2016 |
75 |
Olympus Corporation of the Americas |
II |
Sep-29-2023 |
76 |
Olympus Corporation of the Americas |
II |
Jul-28-2023 |
77 |
Olympus Corporation of the Americas |
II |
Feb-07-2023 |
78 |
PHILIPS HEADQUARTERS CAMBRIDGE |
II |
May-23-2023 |
79 |
PHILIPS MEDICAL SYSTEMS |
II |
Feb-08-2024 |
80 |
Philips And Neusoft Medical Systems Co., Ltd. |
II |
Apr-23-2013 |
81 |
Philips And Neusoft Medical Systems Co., Ltd. |
II |
Dec-04-2012 |
82 |
Philips And Neusoft Medical Systems Co., Ltd. |
II |
Jul-26-2012 |
83 |
Philips And Neusoft Medical Systems Co., Ltd. |
II |
May-23-2011 |
84 |
Philips And Neusoft Medical Systems Co., Ltd. |
II |
Jan-04-2011 |
85 |
Philips Electronics North America Corporation |
II |
Oct-13-2017 |
86 |
Philips Electronics North America Corporation |
II |
Nov-22-2016 |
87 |
Philips Electronics North America Corporation |
II |
Dec-12-2015 |
88 |
Philips Healthcare |
II |
Sep-30-2023 |
89 |
Philips Healthcare |
II |
Jun-06-2016 |
90 |
Philips Healthcare (Suzhou) Co., Ltd. |
II |
Jan-05-2024 |
91 |
Philips Healthcare (Suzhou) Co., Ltd. |
II |
Mar-17-2021 |
92 |
Philips Healthcare Inc. |
II |
Apr-17-2013 |
93 |
Philips Healthcare Inc. |
II |
Dec-14-2010 |
94 |
Philips Medical Systems |
II |
Mar-04-2011 |
95 |
Philips Medical Systems |
II |
Oct-04-2016 |
96 |
Philips Medical Systems (Cleveland) Inc |
II |
Aug-06-2019 |
97 |
Philips Medical Systems (Cleveland) Inc |
II |
Apr-13-2019 |
98 |
Philips Medical Systems (Cleveland) Inc |
II |
Nov-30-2018 |
99 |
Philips Medical Systems (Cleveland) Inc |
II |
Oct-31-2018 |
100 |
Philips Medical Systems (Cleveland) Inc |
II |
Jul-02-2018 |
|
|
|
|