| Device Type ID | 5318 |
| Device Name | Tube Mount, X-ray, Diagnostic |
| Regulation Description | Diagnostic X-ray Tube Mount. |
| 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 | 892.1770 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IYB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5318 |
| Device | Tube Mount, X-ray, Diagnostic |
| Product Code | IYB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Diagnostic X-ray Tube Mount. |
| CFR Regulation Number | 892.1770 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 1 |
Device Issue | 1 |
Unintended System Motion | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Medical Solutions USA, Inc | II | Aug-17-2018 |
| 2 | Summit Industries Inc. | II | Dec-01-2014 |