|
Device |
system, x-ray, stationary |
Product Code | KPR |
Regulation Number |
892.1680
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ADANI |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALLENGERS MEDICAL SYSTEMS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARESTREAM HEALTH, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEL MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRGEM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
EOS IMAGING |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE HUALUN MEDICAL SYSTEMS CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE HUALUN MEDICAL SYSTEMS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HALIFAX BIOMEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JPI HEALTHCARE CO, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KONICA MINOLTA HEALTHCARE AMERICAS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LIVERMORETECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICATECH USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANORAY BIOTECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS HEALTHCARE (SUZHOU) CO., LIT. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS HEALTHCARE (SUZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS DMC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADMEDIX LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAMSUNG ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SAMSUNG ELECTRONICS CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SEDECAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEDECAL, SA. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SG HEALTHCARE CO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHIMADZU CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
SIEMENS MEDICAL SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SKANRAY TECHNOLOGIES LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUMMIT INDUSTRIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEVERE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VMI TECNOLOGIAS LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XERA MEDICAL SYSTEMS & TECHNOLOGY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XORAN TECHNOLOGIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Agfa N.V. |
II |
Sep-25-2018 |
2 |
Agfa-Gevaert, N.V. |
II |
Jan-07-2019 |
3 |
Arcoma AB |
II |
Jul-05-2022 |
4 |
Carestream Health, Inc. |
II |
Mar-02-2023 |
5 |
Carestream Health, Inc. |
II |
Jan-13-2020 |
6 |
Cuattro LLC |
II |
May-08-2020 |
7 |
EOS Imaging |
II |
Apr-13-2021 |
8 |
GE Healthcare, LLC |
II |
Sep-20-2019 |
9 |
GE Healthcare, LLC |
II |
Jun-10-2019 |
10 |
GE Healthcare, LLC |
II |
Jul-16-2018 |
11 |
NeuroLogica Corporation |
II |
Mar-02-2018 |
12 |
Philips Electronics North America Corporation |
II |
Jan-03-2018 |
13 |
Philips Healthcare |
II |
Sep-20-2019 |
14 |
Philips Medical Systems DMC GmbH |
II |
Jul-12-2022 |
15 |
Philips Medical Systems Nederland B.V. |
II |
Sep-07-2023 |
16 |
Philips Medical Systems Nederlands |
II |
May-03-2018 |
17 |
Philips North America, LLC |
II |
Apr-28-2020 |
18 |
Philips North America, LLC |
II |
Mar-23-2019 |
19 |
Philips North America Llc |
II |
Apr-12-2023 |
20 |
Philips North America Llc |
II |
Sep-01-2022 |
21 |
Shanghai United Imaging Healthcare Co., Ltd. |
II |
May-12-2022 |
22 |
Shanghai United Imaging Healthcare Co., Ltd. |
II |
Mar-02-2021 |
23 |
Shanghai United Imaging Healthcare Co., Ltd. |
II |
Jul-08-2020 |
24 |
Siemens Medical Solutions USA, Inc |
II |
Apr-05-2022 |
25 |
Siemens Medical Solutions USA, Inc |
II |
Mar-30-2022 |
26 |
Siemens Medical Solutions USA, Inc |
II |
Apr-02-2021 |
27 |
Siemens Medical Solutions USA, Inc |
II |
Aug-05-2020 |
28 |
Siemens Medical Solutions USA, Inc |
II |
May-05-2020 |
29 |
Siemens Medical Solutions USA, Inc |
II |
Mar-03-2020 |
30 |
Siemens Medical Solutions USA, Inc |
II |
Feb-20-2020 |
31 |
Siemens Medical Solutions USA, Inc |
II |
Oct-30-2018 |
32 |
Siemens Medical Solutions USA, Inc |
II |
Oct-30-2018 |
33 |
Swissray Medical |
II |
Sep-25-2018 |
34 |
Swissray Medical |
II |
Sep-18-2018 |
35 |
Visaris DOO |
II |
May-15-2018 |
|
|
|
|