The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Phoenix Plus & Base Nuclear Medicine Single Detector Systems.
| Device ID | K951144 |
| 510k Number | K951144 |
| Device Name: | PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS 3000 N GRANDVIEW BLVD. W-709 Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS 3000 N GRANDVIEW BLVD. W-709 Waukesha, WI 53188 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-13 |
| Decision Date | 1995-07-03 |