The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Vpc-94 Ultra High Energy Collimaters Model Numbers 480-685-9402.
| Device ID | K981352 |
| 510k Number | K981352 |
| Device Name: | VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS F.I. HAIFA ADVANCED TECHNOLOGY CENTER Haifa, IL 31004 |
| Contact | Yair Friedman |
| Correspondent | Yair Friedman GE MEDICAL SYSTEMS F.I. HAIFA ADVANCED TECHNOLOGY CENTER Haifa, IL 31004 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-14 |
| Decision Date | 1998-07-13 |
| Summary: | summary |