GATED MIBI 3-D EJECTION FRACTION PROCESSING
Device Facts
| Record ID | K961597 |
|---|---|
| Device Name | GATED MIBI 3-D EJECTION FRACTION PROCESSING |
| Applicant | Trionix Research Laboratory, Inc. |
| Product Code | KPS · Radiology |
| Decision Date | Sep 4, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1200 |
| Device Class | Class 2 |
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.
