| Device Type ID | 5392 |
| Device Name | Solid State X-ray Imager (flat Panel/digital Imager) |
| Regulation Description | Stationary X-ray System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1680 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MQB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5392 |
| Device | Solid State X-ray Imager (flat Panel/digital Imager) |
| Product Code | MQB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stationary X-ray System. |
| CFR Regulation Number | 892.1680 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
2020 IMAGING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
3DISC AMERICAS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AGFA HEALTHCARE N.V. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
ATLAIM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOKINEMETRICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CANON, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
CARESTREAM HEALTH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARESTREAM HEALTH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEL MEDICAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DRTECH CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJI | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FUJIFILM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
IMAGING DYNAMICS COMPANY LTD. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
INNOLUX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IRAY TECHNOLOGY (SHANGHAI) LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KONICA MINOLTA HEALTHCARE AMERICAS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
KONICA MINOLTA, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KONICA MINOLTA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 11 | |
KUB TECHNOLOGIES, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LG ELECTRONICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LG ELECTRONICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDIEN INTERNATIONAL CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIDIAN MEDICAL SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OEHM UND REHBEIN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSKO, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PERKINELMER, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PERKINELMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PHILIPS MEDICAL SYSTEMS DMC GMBH | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
PORTAVISION MEDICAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RADIOLOGY SOLUTIONS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RADLINK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RAYENCE CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 12 | |
RAYENCE CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SAMSUNG ELECTRONICS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
SEDECAL SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEVERE SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VAREX IMAGING CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
VARIAN MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VIEWORKS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Device Operational Issue | 80 |
Device Operates Differently Than Expected | 4 |
Device Inoperable | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Device Displays Incorrect Message | 2 |
Image Display Error / Artifact | 2 |
Computer Operating System Problem | 1 |
Human Factors Issue | 1 |
Installation-Related Problem | 1 |
Interface | 1 |
Component Falling | 1 |
Computer Software Problem | 1 |
Overheating Of Device | 1 |
Appropriate Term/Code Not Available | 1 |
Loss Of Data | 1 |
Facilities Issue | 1 |
Operating System Becomes Nonfunctional | 1 |
| Total Device Problems | 103 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | AGFA Healthcare Corp. | II | Jul-14-2017 |
| 2 | Canon Medical System, USA, INC. | II | Aug-31-2018 |
| 3 | EOS Imaging | II | Jan-09-2014 |
| 4 | Eos Imaging Inc | II | May-05-2015 |
| 5 | GE Healthcare, LLC | II | Feb-24-2014 |
| 6 | Konica Minolta Medical Imaging USA, Inc. | II | Jun-22-2018 |
| 7 | LIEBEL-FLARSHEIM COMPANY LLC | II | Aug-21-2018 |
| 8 | NeuroLogica Corporation | II | Apr-17-2018 |
| 9 | Philips Electronics North America Corporation | II | Feb-23-2018 |
| 10 | Philips Electronics North America Corporation | II | Jun-09-2017 |
| 11 | Philips Electronics North America Corporation | II | Nov-11-2015 |
| 12 | Philips Healthcare | II | Jun-03-2016 |
| 13 | Philips Medical Systems Gmbh, DMC | II | Oct-24-2018 |
| 14 | Philips Medical Systems Gmbh, DMC | II | Aug-17-2018 |
| 15 | Philips Medical Systems, Inc. | II | May-19-2015 |
| 16 | Sedecal S.A. | II | Nov-20-2018 |
| 17 | Swissray Medical AG | II | Jan-08-2019 |
| 18 | Toshiba American Medical Systems | II | Sep-11-2017 |
| 19 | Toshiba American Medical Systems Inc | II | Jun-04-2014 |
| 20 | Virtual Imaging, Inc. | II | Nov-14-2018 |