The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Hawkeye Option For Dual-head Variable Angle Gamma Camera.
| Device ID | K991841 |
| 510k Number | K991841 |
| Device Name: | HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS F.I. HAIFA P.O. BOX 170 Tirat Hacarmel, IL 30200 |
| Contact | Dan Laor |
| Correspondent | Dan Laor GE MEDICAL SYSTEMS F.I. HAIFA P.O. 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 | 1999-05-28 |
| Decision Date | 1999-08-26 |
| Summary: | summary |