The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Vtransact: Attenuation Correction System For Dual-head Variable Angle Gamma Camera.
| Device ID | K980959 |
| 510k Number | K980959 |
| Device Name: | VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS F.I. HAIFA PO BOX 170 Tirat Hacarmel, IL 30200 |
| Contact | Yair Friedman |
| Correspondent | Yair Friedman GE MEDICAL SYSTEMS F.I. HAIFA PO BOX 170 Tirat Hacarmel, IL 30200 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-14 |
| Decision Date | 1998-06-04 |
| Summary: | summary |