| Device Type ID | 5282 |
| Device Name | Monitor, Patient Position, Light-beam |
| Regulation Description | Light Beam Patient Position Indicator. |
| 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 | 892.5780 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IWE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5282 |
| Device | Monitor, Patient Position, Light-beam |
| Product Code | IWE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Light Beam Patient Position Indicator. |
| CFR Regulation Number | 892.5780 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GAMMEX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Separation | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | GE Healthcare | II | May-01-2015 |
| 2 | Omega Medical Imaging, Inc. | II | Jun-19-2017 |