The following data is part of a premarket notification filed by Adac Laboratories with the FDA for New Detector For Transcam/polaris S315.
| Device ID | K924639 |
| 510k Number | K924639 |
| Device Name: | NEW DETECTOR FOR TRANSCAM/POLARIS S315 |
| Classification | Camera, Scintillation (gamma) |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Paul Vicha |
| Correspondent | Paul Vicha ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-02 |
| Decision Date | 1993-01-15 |