K951144 is an FDA 510(k) clearance for the PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS. This device is classified as a System, Tomography, Computed, Emission (Class II - Special Controls, product code KPS).
Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on July 3, 1995, 112 days after receiving the submission on March 13, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K951144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 1995 |
| Decision Date | July 03, 1995 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPS - System, Tomography, Computed, Emission |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1200 |