|
Device |
system, tomography, computed, emission |
Product Code | KPS |
Regulation Number |
892.1200
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
CANON MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CARDIOVASCULAR IMAGING TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COMBINOSTICS OY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVER FORTUNE.AI CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS SCS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GE MEDICAL SYSTEMS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HERMES MEDICAL SOLUTIONS AB |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MCGOVERN MEDICAL SCHOOL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MIEGMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
POSITRIGO AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRESCIENT IMAGING, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADIALIS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS HEALTHINEERS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTION USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
SIRTEX MEDICAL US HOLDINGS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPECTRUM DYNAMICS MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SUBTLE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTERMED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Canon Medical System, USA, INC. |
II |
Nov-01-2024 |
2 |
Canon Medical System, USA, INC. |
II |
Oct-19-2021 |
3 |
GE Healthcare, LLC |
II |
May-11-2021 |
4 |
GE Healthcare, LLC |
II |
Jan-13-2021 |
5 |
GE Healthcare, LLC |
II |
Sep-21-2020 |
6 |
GE Healthcare, LLC |
II |
Jun-03-2020 |
7 |
GE Healthcare, LLC |
II |
Jun-19-2019 |
8 |
GE Healthcare, LLC |
II |
Jan-09-2019 |
9 |
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
II |
Jun-07-2024 |
10 |
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
I |
Feb-08-2023 |
11 |
Philips Medical Systems (Cleveland) Inc |
I |
Nov-01-2019 |
12 |
Philips Medical Systems (Cleveland) Inc |
II |
Jul-22-2019 |
13 |
Philips Medical Systems (Cleveland) Inc |
II |
Jul-03-2019 |
14 |
Philips Medical Systems (Cleveland) Inc |
II |
Feb-12-2019 |
15 |
Philips North America |
I |
Feb-02-2024 |
16 |
Philips North America |
II |
Jan-05-2024 |
17 |
Philips North America Llc |
II |
Nov-24-2021 |
18 |
Philips North America Llc |
II |
Jun-30-2021 |
19 |
Shanghai United Imaging Healthcare Co., Ltd. |
II |
Apr-07-2023 |
20 |
Shanghai United Imaging Healthcare Co., Ltd. |
II |
Oct-13-2022 |
21 |
Shanghai United Imaging Healthcare Co., Ltd. |
II |
Sep-29-2021 |
22 |
Shanghai United Imaging Healthcare Co., Ltd. |
II |
Nov-12-2020 |
23 |
Shanghai United Imaging Healthcare Co., Ltd. |
II |
Aug-18-2020 |
24 |
Shanghai United Imaging Healthcare Co., Ltd. |
II |
Aug-13-2020 |
25 |
Shanghai United Imaging Healthcare Co., Ltd. |
II |
Apr-15-2020 |
26 |
Siemens Medical Solutions USA, Inc. |
II |
Jul-28-2023 |
27 |
Siemens Medical Solutions USA, Inc. |
II |
Feb-13-2023 |
28 |
Siemens Medical Solutions USA, Inc. |
II |
Apr-07-2022 |
29 |
Siemens Medical Solutions USA, Inc. |
II |
Sep-02-2020 |
30 |
Siemens Medical Solutions USA, Inc. |
II |
Aug-27-2020 |
31 |
Siemens Medical Solutions USA, Inc. |
II |
Jan-10-2019 |
|
|
|
|