| Device Type ID | 5374 |
| Device Name | Shield, Protective, Personnel |
| Regulation Description | Personnel Protective Shield. |
| 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 | 892.6500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KPY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5374 |
| Device | Shield, Protective, Personnel |
| Product Code | KPY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Personnel Protective Shield. |
| CFR Regulation Number | 892.6500 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | GE Healthcare | II | Apr-13-2015 |
| 2 | GE Healthcare, LLC | II | Jun-03-2014 |