JUMBO DIGITAL GAMMACAMERA GCA-90B
Device Facts
| Record ID | K851687 |
|---|---|
| Device Name | JUMBO DIGITAL GAMMACAMERA GCA-90B |
| Applicant | Toshiba Medical Systems |
| Product Code | JWM · Radiology |
| Decision Date | Jun 5, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1310 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of devices may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
