The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Hawkeye 4 Option For Dual-head Variable Angle Gamma Camera.
| Device ID | K052434 |
| 510k Number | K052434 |
| Device Name: | HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS 4 HAYOZMA ST. P.O. BOX 170 Tirat Hacarmel, IL 30200 |
| Contact | Eli Werner |
| Correspondent | Eli Werner GE MEDICAL SYSTEMS 4 HAYOZMA ST. P.O. BOX 170 Tirat Hacarmel, IL 30200 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-06 |
| Decision Date | 2005-09-27 |
| Summary: | summary |