| Device Type ID | 5354 |
| Device Name | System, X-ray, Film Marking, Radiographic |
| Regulation Description | Radiographic Film Marking System. |
| 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 | 892.1640 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JAC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5354 |
| Device | System, X-ray, Film Marking, Radiographic |
| Product Code | JAC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Radiographic Film Marking System. |
| CFR Regulation Number | 892.1640 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beekley Corporation | II | Aug-16-2018 |
| 2 | Beekley Corporation | III | Jun-27-2017 |