GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM
Device Facts
| Record ID | K901545 |
|---|---|
| Device Name | GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM |
| Applicant | Toshiba America Medical Systems, In.C |
| Product Code | JWM · Radiology |
| Decision Date | Jun 26, 1990 |
| 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.
