The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Apollo Gamma Camera System.
| Device ID | K062298 |
| 510k Number | K062298 |
| Device Name: | APOLLO GAMMA CAMERA SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Annie Wright |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-08-08 |
| Decision Date | 2006-08-23 |
| Summary: | summary |