The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Adac Tomography Option.
| Device ID | K791055 |
| 510k Number | K791055 |
| Device Name: | ADAC TOMOGRAPHY OPTION |
| Classification | System, Tomography, Computed, Emission |
| Applicant | ADAC LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-07 |
| Decision Date | 1979-09-17 |