The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Ge Quasar Nuclear Medicine System.
| Device ID | K022960 |
| 510k Number | K022960 |
| Device Name: | GE QUASAR NUCLEAR MEDICINE SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS F.I. HAIFA 10 HAYOZMA ST. Tirat Hacarmel, IL 30200 |
| Contact | Hemy Neuman |
| Correspondent | Heinz Joerg Steneberg TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-09-06 |
| Decision Date | 2002-09-19 |
| Summary: | summary |