| Device Type ID | 5344 |
| Device Name | System, X-ray, Mobile |
| Regulation Description | Mobile 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 | 892.1720 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IZL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 5344 |
| Device | System, X-ray, Mobile |
| Product Code | IZL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Mobile X-ray System. |
| CFR Regulation Number | 892.1720 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AJEX MEDITECH., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEL MEDICAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTAL IMAGING TECHNOLGIES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEXCOWIN CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DRGEM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJIFILM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GE HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
GENERAL ELECTRIC CO. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
HITACHI MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HITACHI MEDICAL SYSTEMS AMERICA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KONICA MINOLTA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KUB TECHNOLOGIES, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIDIAN MEDICAL SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
Minxray Inc | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
OEHM UND REHBEIN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SAMSUNG ELECTRONICS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
SAMSUNG ELECTRONICS CO.,LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEDECAL SA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOLUTIONS FOR TOMORROW AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOURCE-RAY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE KRETCHMER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Unintended Movement | 7 |
Unintended System Motion | 6 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Electrical Shorting | 5 |
Insufficient Information | 4 |
Use Of Device Problem | 4 |
Detachment Of Device Or Device Component | 3 |
Mechanical Problem | 3 |
Computer Software Problem | 3 |
Device Issue | 3 |
Device Handling Problem | 2 |
Break | 2 |
Self-Activation Or Keying | 2 |
Data Problem | 2 |
Device Operational Issue | 2 |
Human-Device Interface Problem | 2 |
Device Component Or Accessory | 1 |
Brake | 1 |
Fire | 1 |
Sparking | 1 |
Device Stops Intermittently | 1 |
Device Inoperable | 1 |
Battery Problem | 1 |
Electronic Property Issue | 1 |
Material Integrity Problem | 1 |
Device Displays Incorrect Message | 1 |
Appropriate Term/Code Not Available | 1 |
Screw | 1 |
Cord | 1 |
Failure To Charge | 1 |
Disassembly | 1 |
Device Difficult To Setup Or Prepare | 1 |
Smoking | 1 |
Collapse | 1 |
Overheating Of Device | 1 |
Device Slipped | 1 |
Unintended Arm Motion | 1 |
Low Battery | 1 |
Misassembly During Maintenance / Repair | 1 |
Thermal Decomposition Of Device | 1 |
Component Falling | 1 |
Environmental Compatibility Problem | 1 |
Motor Drive Unit | 1 |
Power Cord | 1 |
Plug | 1 |
Cover | 1 |
Device Maintenance Issue | 1 |
Unintended Collision | 1 |
Arcing | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
| Total Device Problems | 89 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | AGFA Corp. | II | Jul-21-2014 |
| 2 | AGFA Healthcare Corp. | II | Jun-10-2015 |
| 3 | AGFA Healthcare Corp. | III | Aug-10-2014 |
| 4 | AGFA Healthcare Corp. | II | Mar-29-2017 |
| 5 | Carestream Health Inc | II | Jun-19-2017 |
| 6 | Carestream Health Inc | II | Feb-03-2017 |
| 7 | Carestream Health Inc | II | Dec-16-2014 |
| 8 | Carestream Health Inc. | II | Jan-03-2014 |
| 9 | Carestream Health, Inc. | II | Jan-21-2014 |
| 10 | Fujifilm Medical Systems U.S.A., Inc. | II | Mar-21-2019 |
| 11 | GE Healthcare | II | Apr-27-2015 |
| 12 | GE Healthcare, LLC | II | Jan-11-2014 |
| 13 | GE Medical Systems, LLC | II | Feb-08-2016 |
| 14 | Philips Healthcare Inc. | II | Apr-04-2017 |
| 15 | Philips Medical Systems, Inc. | II | Dec-16-2014 |
| 16 | Sedecal S.A. | II | Mar-08-2016 |
| 17 | Sedecal S.A. | II | Aug-14-2015 |
| 18 | Sedecal S.A. | II | Feb-02-2015 |
| 19 | Sedecal USA, Inc. | II | Jun-03-2016 |
| 20 | Shimadzu Medical Systems | II | Dec-18-2015 |
| 21 | Shimadzu Medical Systems | II | Mar-07-2014 |
| 22 | Shimadzu Medical Systems Usa Com | II | Mar-21-2019 |
| 23 | Siemens Medical Solutions USA, Inc | II | Jul-02-2014 |
| 24 | Trans American Medical, Inc. | II | Jan-03-2014 |
| 25 | Virtual Imaging, Inc. | II | Feb-09-2015 |