| Device Type ID | 5338 |
| Device Name | Probe, Uptake, Nuclear |
| Regulation Description | Nuclear Uptake Probe. |
| 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 | 892.1320 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IZD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5338 |
| Device | Probe, Uptake, Nuclear |
| Product Code | IZD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nuclear Uptake Probe. |
| CFR Regulation Number | 892.1320 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SURGICEYE GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Detachment Of Device Component | 5 |
Mechanical Problem | 3 |
Loss Of Or Failure To Bond | 2 |
Detachment Of Device Or Device Component | 1 |
Component Falling | 1 |
Material Separation | 1 |
| Total Device Problems | 13 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Capintec Inc | II | Dec-04-2018 |