ICON COMPUTER SYSTEM
Device Facts
| Record ID | K914350 |
|---|---|
| Device Name | ICON COMPUTER SYSTEM |
| Applicant | Siemens Gammasonics, Inc. |
| Product Code | JWM · Radiology |
| Decision Date | Nov 22, 1991 |
| 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.
