|
Device |
solid state x-ray imager (flat panel/digital imager) |
Product Code | MQB |
Regulation Number |
892.1680
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
2020 IMAGING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3DISC AMERICAS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
5 STAR MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ABYZR CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AGFA HEALTHCARE N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
AGFA N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AIR TECHNIQUES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALARA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALLENGERS MEDICAL SYSTEMS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALMANA MEDICAL IMAGING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTEL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ATLAIM |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ATLAIM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOKINEMETRICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BONTECH CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BONTECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CANON INC. |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
CANON U.S.A., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANON, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CANON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
CANON, INC. – MEDICAL EQUIPMENT GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANON, INC.-MEDICAL EQUIPMENT GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CARESTREAM HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARESTREAM HEALTH, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
CARESTREAM HEALTH,INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COMED CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEL MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTIUM CO., LTD (ICT BRANCH) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DRTECH CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DRTECH CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
1. K142475 EVS 4343
|
2. K151942 EVS 3643
|
3. K162552 EVS 3643, EVS 3643G
|
4. K162555 EVS 4343, EVS 4343G
|
5. K171137 EVS 2430W, EVS 2430GW
|
6. K192400 EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
|
7. K193017 EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / ...
|
8. K193031 EXPD 4343P, EXPD 3643P
|
9. K223124 EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
|
10. K231959 EXPD 4357; EXPD 4357P
|
11. K232082 EXPD 4343S
|
12. K232753 EXPD 4343D; EXPD 3643D
|
E-WOO TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EOS IMAGING |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FIRST SOURCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
FUJIFILM MEDICAL SYSTEMS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
H&ABYZ |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
H&ABYZ CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HUMANRAY CO,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ICRCO INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMAGING DYNAMICS COMPANY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
INNOCARE OPTOELECTRONICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
INNOLUX CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IRAY TECHNOLOGY (SHANGHAI) LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IRAY TECHNOLOGY TAICANG LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
17
|
JPI HEALTHCARE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JPI HEALTHCARE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KA IMAGING INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KONICA MINOLTA HEALTHCARE AMERICAS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
KONICA MINOLTA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KONICA MINOLTA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
KUB TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LED DENTAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LG ELECTRONICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LG ELECTRONICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
LIEBEL-FLARSHEIM |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIVERMORETECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICATECH USA |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDIEN INTERNATIONAL CO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIEN INTERNATIONAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIDIAN MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
NEUROLOGICA CORPORATION, A SUBSIDIARY OF |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEW MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OEHM UND REHBEIN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OSKO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PERKINELMER, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERKINELMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PHILIPS MEDICAL SYSTEMS DMC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIXXGEN CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PORTAVISION MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PZMEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADIOLOGY SOLUTIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADISEN CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADISEN INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADLINK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADMEDIX LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
RAY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RAY IMAGING TECHNOLOGY (HAINING) LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RAYENCE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
25
|
RAYENCE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SAMSUNG ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SAMSUNG MOBILE DISPLAY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SEDECAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SEHYUN CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI PZ MEDICAL TECHNOLGOY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIMONDR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SWISSRAY MEDICAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TELEVERE SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VAREX IMAGING CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VATECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VIEWORKS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VIEWORKS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
VIZTEK LLC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
AGFA Corp. |
II |
Mar-19-2013 |
2 |
AGFA Corp. |
II |
Feb-19-2012 |
3 |
AGFA Corp. |
II |
Jan-11-2012 |
4 |
AGFA Corp. |
II |
May-04-2011 |
5 |
AGFA Corp. |
II |
Nov-26-2010 |
6 |
AGFA Corp. |
II |
Jul-26-2010 |
7 |
AGFA Healthcare Corp. |
II |
Jul-14-2017 |
8 |
Canon Inc. |
II |
Aug-24-2012 |
9 |
Canon Medical System, USA, INC. |
II |
Mar-17-2021 |
10 |
Canon Medical System, USA, INC. |
II |
Mar-09-2021 |
11 |
Canon Medical System, USA, INC. |
II |
Jun-09-2020 |
12 |
Canon Medical System, USA, INC. |
II |
Nov-12-2019 |
13 |
Canon Medical System, USA, INC. |
II |
Jul-11-2019 |
14 |
Canon Medical System, USA, INC. |
II |
Aug-31-2018 |
15 |
Carestream Health Inc. |
II |
Nov-07-2013 |
16 |
Carestream Health, Inc. |
II |
Aug-13-2012 |
17 |
Cooper Surgical, Inc. |
II |
Apr-03-2013 |
18 |
EOS Imaging |
II |
Jan-09-2014 |
19 |
Eos Imaging Inc |
II |
May-05-2015 |
20 |
Eos Imaging Inc |
II |
Sep-28-2012 |
21 |
GE Healthcare, LLC |
II |
Feb-24-2014 |
22 |
GE Healthcare, LLC |
II |
Mar-13-2013 |
23 |
GE Healthcare, LLC |
II |
Mar-11-2013 |
24 |
GE Healthcare, LLC |
II |
Sep-13-2012 |
25 |
GE Healthcare, LLC |
II |
Oct-28-2011 |
26 |
GE Healthcare, LLC |
II |
Nov-17-2010 |
27 |
GE Healthcare, LLC |
II |
Nov-16-2010 |
28 |
GE Healthcare, LLC |
II |
Aug-19-2010 |
29 |
GE Medical Systems, LLC |
II |
Jan-13-2010 |
30 |
GE Medical Systems, LLC |
II |
Dec-16-2009 |
31 |
GE Medical Systems, LLC |
II |
Nov-09-2009 |
32 |
GE Medical Systems, LLC |
II |
Sep-24-2009 |
33 |
GE Medical Systems, LLC |
II |
Sep-24-2009 |
34 |
GE Medical Systems, LLC |
II |
Jun-19-2009 |
35 |
GE Medical Systems, LLC |
II |
May-19-2009 |
36 |
GE Medical Systems, LLC |
II |
Mar-12-2009 |
37 |
GE Medical Systems, LLC |
II |
Jan-21-2009 |
38 |
Ge Healthcare |
II |
Sep-24-2009 |
39 |
Ge Healthcare, Llc |
II |
Jun-29-2010 |
40 |
Ge Healthcare, Llc |
II |
May-26-2010 |
41 |
General Electric Med Systems LLC |
II |
Jun-08-2012 |
42 |
Konica Minolta Medical Imaging USA, Inc. |
II |
Jun-22-2018 |
43 |
LIEBEL-FLARSHEIM COMPANY LLC |
II |
Jul-02-2021 |
44 |
LIEBEL-FLARSHEIM COMPANY LLC |
II |
Aug-21-2018 |
45 |
NeuroLogica Corporation |
II |
Apr-17-2018 |
46 |
Palodex Group Oy |
II |
Jan-24-2020 |
47 |
Philips Electronics North America Corporation |
II |
Feb-23-2018 |
48 |
Philips Electronics North America Corporation |
II |
Jun-09-2017 |
49 |
Philips Electronics North America Corporation |
II |
Nov-11-2015 |
50 |
Philips Healthcare |
II |
Nov-24-2021 |
51 |
Philips Healthcare |
II |
Jun-03-2016 |
52 |
Philips Healthcare Inc. |
II |
Jun-17-2013 |
53 |
Philips Healthcare Inc. |
II |
Mar-01-2013 |
54 |
Philips Healthcare Inc. |
II |
Feb-26-2013 |
55 |
Philips Healthcare Inc. |
II |
Dec-05-2012 |
56 |
Philips Healthcare Inc. |
II |
Sep-28-2012 |
57 |
Philips Healthcare Inc. |
II |
Sep-27-2012 |
58 |
Philips Healthcare Inc. |
II |
Sep-14-2012 |
59 |
Philips Healthcare Inc. |
II |
Jun-15-2012 |
60 |
Philips Healthcare Inc. |
II |
Apr-26-2012 |
61 |
Philips Healthcare Inc. |
II |
Nov-30-2011 |
62 |
Philips Medical Systems Gmbh, DMC |
II |
Oct-24-2018 |
63 |
Philips Medical Systems Gmbh, DMC |
II |
Aug-17-2018 |
64 |
Philips Medical Systems North America Co. Phillips |
II |
Mar-23-2010 |
65 |
Philips Medical Systems, Inc. |
II |
May-19-2015 |
66 |
Philips Medical Systems, Inc. |
II |
Dec-27-2013 |
67 |
Philips North America Llc |
II |
Jun-30-2023 |
68 |
Sedecal S.A. |
II |
Nov-20-2018 |
69 |
Siemens Medical Solutions USA, Inc |
II |
May-05-2020 |
70 |
Siemens Medical Solutions USA, Inc |
II |
Jul-24-2013 |
71 |
Siemens Medical Solutions USA, Inc |
II |
Apr-09-2012 |
72 |
Siemens Medical Solutions USA, Inc |
II |
Mar-05-2012 |
73 |
Siemens Medical Solutions USA, Inc |
II |
Jan-25-2012 |
74 |
Siemens Medical Solutions USA, Inc |
II |
Jul-11-2011 |
75 |
Siemens Medical Solutions USA, Inc |
II |
Feb-23-2011 |
76 |
Siemens Medical Solutions USA, Inc |
II |
Dec-17-2010 |
77 |
Siemens Medical Solutions USA, Inc |
II |
Aug-13-2010 |
78 |
Siemens Medical Solutions USA, Inc |
II |
May-28-2010 |
79 |
Siemens Medical Solutions USA, Inc |
II |
Apr-05-2010 |
80 |
Siemens Medical Solutions USA, Inc |
II |
May-06-2009 |
81 |
Swissray Medical AG |
II |
Jan-08-2019 |
82 |
Toshiba American Medical Systems |
II |
Sep-11-2017 |
83 |
Toshiba American Medical Systems Inc |
II |
Jun-04-2014 |
84 |
Toshiba American Medical Systems Inc |
II |
Mar-25-2013 |
85 |
Toshiba American Medical Systems Inc |
II |
Feb-02-2012 |
86 |
Toshiba American Medical Systems Inc |
II |
Dec-01-2011 |
87 |
Toshiba American Medical Systems Inc |
II |
Mar-22-2010 |
88 |
Toshiba American Medical Systems Inc |
II |
Sep-28-2009 |
89 |
Virtual Imaging, Inc. |
II |
Nov-14-2018 |
|
|
|
|