The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Adac Viewpoint (additional Software).
| Device ID | K884349 |
| 510k Number | K884349 |
| Device Name: | ADAC VIEWPOINT (ADDITIONAL SOFTWARE) |
| Classification | System, Tomography, Computed, Emission |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Larry Hernandez |
| Correspondent | Larry Hernandez ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-12 |
| Decision Date | 1988-12-22 |