IZC · Camera, Positron
Radiology · 21 CFR 892.1110 · Class 1
Overview
| Product Code | IZC |
|---|---|
| Device Name | Camera, Positron |
| Regulation | 21 CFR 892.1110 |
| Device Class | Class 1 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A positron camera is a device intended to image the distribution of positron-emitting radionuclides in the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
