| Device Type ID | 5314 |
| Device Name | Table, Radiographic, Tilting |
| Regulation Description | Radiologic Table. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 892.1980 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IXR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5314 |
| Device | Table, Radiographic, Tilting |
| Product Code | IXR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Radiologic Table. |
| CFR Regulation Number | 892.1980 [🔎] |
| Device Problems | |
|---|---|
Unintended Movement | 14 |
Detachment Of Device Component | 4 |
Device Inoperable | 3 |
Circuit Failure | 2 |
Device Displays Incorrect Message | 2 |
Component Falling | 2 |
Mechanical Problem | 2 |
Knife | 1 |
Positioning Problem | 1 |
Device Maintenance Issue | 1 |
Unintended Collision | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Foot Pedal | 1 |
Unintended System Motion | 1 |
Inadequate Service | 1 |
High Test Results | 1 |
Difficult To Open Or Close | 1 |
Unstable | 1 |
Radiation Overexposure | 1 |
Table | 1 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 44 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | GE Healthcare, LLC | II | May-22-2017 |
| 2 | GE Healthcare, LLC | II | Dec-23-2016 |
| 3 | LIEBEL-FLARSHEIM COMPANY LLC | II | Aug-21-2018 |
| 4 | Oakworks Inc | II | Feb-23-2018 |
| 5 | Philips Electronics North America Corporation | II | Aug-01-2016 |
| 6 | Philips Medical Systems Nederlands | II | May-03-2018 |
| 7 | Philips North America, LLC | II | Mar-23-2019 |
| 8 | Shimadzu Medical Systems | II | Apr-28-2016 |