VISION FX 40 & 80 SERIES GAMMA CAMERA
Device Facts
| Record ID | K935273 |
|---|---|
| Device Name | VISION FX 40 & 80 SERIES GAMMA CAMERA |
| Applicant | Summit Nuclear |
| Product Code | IYX · Radiology |
| Decision Date | Apr 18, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1100 |
| Device Class | Class 1 |
Regulatory Classification
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.
