21 CFR 892.1100 — Camera, Scintillation (Gamma)
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1100
Identification
A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 |
|---|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | 1 | 130 | 3rd Party |
