|
Device |
system, x-ray, mobile |
Product Code | IZL |
Regulation Number |
892.1720
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AGFA HEALTHCARE N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AGFA N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AJEX MEDITECH., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARIBEX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASPENSTATE INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CMT MEDICAL TECHNOLOGIES, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K100400 PRESTODR PORTABLE
|
DEL MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEXCOWIN CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRGEM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ECOTRON CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FIRST SOURCE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
HDT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUESTIS MACHINE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOB CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KUB TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIVERMORETECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIDIAN MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO-X LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO-X LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MINXRAY, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MINXRAY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
NANJING PERLOVE MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANO-X IMAGING LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUF INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OEHM UND REHBEIN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OXOS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PHILIPS INDIA LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS DMC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POSKOM CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADMEDIX LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REMEDI CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAMSUNG ELECTRONICS CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAMSUNG ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SAMSUNG ELECTRONICS CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEDECAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SEDECAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
SEDECAL, SA. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEDECAL., SA. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI) |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SHENZHEN BROWINER TECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHIMADZU CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKANRAY TECHNOLOGIES LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOLUTIONS FOR TOMORROW AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOURCE-RAY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STEPHANIX |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU POWERSITE ELECTRIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRANSAMERICAN MEDICAL IMAGING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VATECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VMI TECNOLOGIAS LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VSI CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
AGFA Corp. |
II |
Jul-21-2014 |
2 |
AGFA Corp. |
II |
Jun-06-2013 |
3 |
AGFA Healthcare Corp. |
II |
Jun-10-2015 |
4 |
AGFA Healthcare Corp. |
III |
Aug-10-2014 |
5 |
AGFA Healthcare Corp. |
II |
Mar-29-2017 |
6 |
AGFA US CORP |
II |
Apr-02-2024 |
7 |
Carestream Health Inc |
II |
Jun-19-2017 |
8 |
Carestream Health Inc |
II |
Feb-03-2017 |
9 |
Carestream Health Inc |
II |
Dec-16-2014 |
10 |
Carestream Health Inc. |
II |
Jan-03-2014 |
11 |
Carestream Health Inc. |
II |
Nov-07-2013 |
12 |
Carestream Health Inc. |
II |
Nov-01-2013 |
13 |
Carestream Health, Inc. |
II |
Dec-01-2023 |
14 |
Carestream Health, Inc. |
II |
Nov-09-2023 |
15 |
Carestream Health, Inc. |
II |
Jan-21-2014 |
16 |
Carestream Health, Inc. |
II |
Oct-31-2013 |
17 |
Carestream Health, Inc. |
II |
Oct-31-2013 |
18 |
FUJIFILM Healthcare Americas Corporation |
II |
Apr-27-2023 |
19 |
Fujifilm Medical Systems U.S.A., Inc. |
II |
Aug-30-2019 |
20 |
Fujifilm Medical Systems U.S.A., Inc. |
II |
Mar-21-2019 |
21 |
GE Healthcare |
II |
Apr-27-2015 |
22 |
GE Healthcare, LLC |
II |
Sep-29-2021 |
23 |
GE Healthcare, LLC |
II |
Jan-11-2014 |
24 |
GE Healthcare, LLC |
II |
Aug-09-2013 |
25 |
GE Healthcare, LLC |
II |
Apr-10-2013 |
26 |
GE Healthcare, LLC |
II |
Nov-29-2012 |
27 |
GE Healthcare, LLC |
II |
Sep-13-2012 |
28 |
GE Healthcare, LLC |
II |
Jul-19-2012 |
29 |
GE Healthcare, LLC |
II |
Apr-24-2012 |
30 |
GE Medical Systems, LLC |
II |
Feb-08-2016 |
31 |
GE OEC Medical Systems, Inc |
II |
Aug-01-2012 |
32 |
Medtronic Navigation, Inc |
II |
Feb-04-2009 |
33 |
Medtronic Navigation, Inc. |
II |
Jun-21-2012 |
34 |
Medtronic Navigation, Inc. |
II |
Nov-23-2010 |
35 |
Micro-X Ltd. |
II |
Sep-23-2022 |
36 |
NeuroLogica Corporation |
II |
Feb-09-2024 |
37 |
NeuroLogica Corporation |
II |
Apr-19-2023 |
38 |
NeuroLogica Corporation |
II |
May-30-2019 |
39 |
Philips Healthcare Inc. |
II |
Apr-04-2017 |
40 |
Philips Healthcare Inc. |
II |
Aug-21-2013 |
41 |
Philips Healthcare Inc. |
II |
Jun-13-2012 |
42 |
Philips Healthcare Inc. |
II |
May-30-2012 |
43 |
Philips Medical Systems North America Co. Phillips |
II |
Mar-08-2011 |
44 |
Philips Medical Systems, Inc. |
II |
Dec-16-2014 |
45 |
SEDECAL SA |
II |
May-02-2024 |
46 |
SEDECAL SA |
II |
Feb-14-2024 |
47 |
SEDECAL SA |
II |
Jun-30-2023 |
48 |
SEDECAL SA |
II |
Mar-02-2023 |
49 |
SEDECAL SA |
II |
Nov-04-2022 |
50 |
Sedecal S.A. |
II |
Mar-08-2016 |
51 |
Sedecal S.A. |
II |
Aug-14-2015 |
52 |
Sedecal S.A. |
II |
Feb-02-2015 |
53 |
Sedecal USA, Inc. |
II |
Jun-03-2016 |
54 |
Shimadzu Medical Systems |
II |
Dec-04-2020 |
55 |
Shimadzu Medical Systems |
II |
Dec-18-2015 |
56 |
Shimadzu Medical Systems |
II |
Mar-07-2014 |
57 |
Shimadzu Medical Systems |
II |
Jun-03-2013 |
58 |
Shimadzu Medical Systems |
II |
Nov-08-2012 |
59 |
Shimadzu Medical Systems Usa Com |
II |
Mar-21-2019 |
60 |
Siemens Medical Solutions USA, Inc |
II |
Nov-14-2023 |
61 |
Siemens Medical Solutions USA, Inc |
II |
Jul-02-2014 |
62 |
Siemens Medical Solutions USA, Inc |
II |
Aug-05-2013 |
63 |
Siemens Medical Solutions USA, Inc |
II |
Dec-06-2012 |
64 |
Siemens Medical Solutions USA, Inc |
II |
Sep-11-2012 |
65 |
Siemens Medical Solutions USA, Inc |
II |
Sep-06-2012 |
66 |
Siemens Medical Solutions USA, Inc |
II |
Aug-11-2011 |
67 |
Siemens Medical Solutions USA, Inc |
II |
Dec-17-2010 |
68 |
Siemens Medical Solutions USA, Inc |
II |
Nov-01-2010 |
69 |
Trans American Medical, Inc. |
II |
Jan-03-2014 |
70 |
Virtual Imaging, Inc. |
II |
Feb-09-2015 |
|
|
|
|