The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Ge Photon Energy Recovery (per) Option.
| Device ID | K023932 |
| 510k Number | K023932 |
| Device Name: | GE PHOTON ENERGY RECOVERY (PER) OPTION |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS F.I. HAIFA 4 HAYOZMA ST., P.O. BOX 170 Tirat Hacarmel, IL 30200 |
| Contact | Hemy Neuman |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-11-26 |
| Decision Date | 2002-12-11 |
| Summary: | summary |