| Device Type ID | 5339 |
| Device Name | System, X-ray, Tomographic |
| Regulation Description | Tomographic 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 | 892.1740 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IZF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5339 |
| Device | System, X-ray, Tomographic |
| Product Code | IZF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tomographic X-ray System. |
| CFR Regulation Number | 892.1740 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Philips Electronics North America Corporation | II | Sep-21-2018 |