21 CFR 892.1110 — Camera, Positron
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1110
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IZC | Camera, Positron | 1 | 0 | 3rd Party |
