UNICORN MODEL SYS0630
Device Facts
| Record ID | K001888 |
|---|---|
| Device Name | UNICORN MODEL SYS0630 |
| Applicant | Danish Diagnostic Development A/S |
| Product Code | KPS · Radiology |
| Decision Date | Jun 30, 2000 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 892.1200 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
Identification
An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
