The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ge Discovery Vct System.
| Device ID | K050559 |
| 510k Number | K050559 |
| Device Name: | GE DISCOVERY VCT SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS 3000 NORTH GRANDVIEW BLVD. W-400 Waukesha, WI 53188 |
| Contact | D Duersteler |
| Correspondent | Tamas Borsai 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 | 2005-03-03 |
| Decision Date | 2005-03-17 |
| Summary: | summary |