DI-2000
Device Facts
| Record ID | K943602 |
|---|---|
| Device Name | DI-2000 |
| Applicant | Miles Inc., Agfa Division |
| Product Code | IYX · Radiology |
| Decision Date | May 12, 1995 |
| 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.
