|
Device |
solid state x-ray imager (flat panel/digital imager) |
Product Code | MQB |
Regulation Number |
892.1680
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AGFA HEALTHCARE N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AGFA N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ASTEL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOKINEMETRICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BONTECH CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BONTECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANON INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
CANON, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CANON, INC. – MEDICAL EQUIPMENT GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARESTREAM HEALTH, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
DENTIUM CO., LTD (ICT BRANCH) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRTECH CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
FIRST SOURCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
H&ABYZ |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
H&ABYZ CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMAGING DYNAMICS COMPANY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
INNOCARE OPTOELECTRONICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
IRAY TECHNOLOGY TAICANG LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
16
|
KA IMAGING INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KONICA MINOLTA HEALTHCARE AMERICAS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KONICA MINOLTA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
LG ELECTRONICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LG ELECTRONICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
LIVERMORETECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIEN INTERNATIONAL CO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUROLOGICA CORPORATION, A SUBSIDIARY OF |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSKO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PHILIPS MEDICAL SYSTEMS DMC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PIXXGEN CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PZMEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADISEN CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADISEN INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADMEDIX LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RAYENCE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
RAYENCE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAMSUNG ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI PZ MEDICAL TECHNOLGOY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEVERE SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VAREX IMAGING CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
VIEWORKS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
AGFA Healthcare Corp. |
II |
Jul-14-2017 |
2 |
Canon Medical System, USA, INC. |
II |
Mar-17-2021 |
3 |
Canon Medical System, USA, INC. |
II |
Mar-09-2021 |
4 |
Canon Medical System, USA, INC. |
II |
Jun-09-2020 |
5 |
Canon Medical System, USA, INC. |
II |
Nov-12-2019 |
6 |
Canon Medical System, USA, INC. |
II |
Jul-11-2019 |
7 |
Canon Medical System, USA, INC. |
II |
Aug-31-2018 |
8 |
Konica Minolta Medical Imaging USA, Inc. |
II |
Jun-22-2018 |
9 |
LIEBEL-FLARSHEIM COMPANY LLC |
II |
Jul-02-2021 |
10 |
LIEBEL-FLARSHEIM COMPANY LLC |
II |
Aug-21-2018 |
11 |
NeuroLogica Corporation |
II |
Apr-17-2018 |
12 |
Palodex Group Oy |
II |
Jan-24-2020 |
13 |
Philips Electronics North America Corporation |
II |
Feb-23-2018 |
14 |
Philips Electronics North America Corporation |
II |
Jun-09-2017 |
15 |
Philips Healthcare |
II |
Nov-24-2021 |
16 |
Philips Medical Systems Gmbh, DMC |
II |
Oct-24-2018 |
17 |
Philips Medical Systems Gmbh, DMC |
II |
Aug-17-2018 |
18 |
Sedecal S.A. |
II |
Nov-20-2018 |
19 |
Siemens Medical Solutions USA, Inc |
II |
May-05-2020 |
20 |
Swissray Medical AG |
II |
Jan-08-2019 |
21 |
Toshiba American Medical Systems |
II |
Sep-11-2017 |
22 |
Virtual Imaging, Inc. |
II |
Nov-14-2018 |
|
|
|
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