The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Pinnacle3 Apex.
| Device ID | K951581 |
| 510k Number | K951581 |
| Device Name: | PINNACLE3 APEX |
| Classification | Accelerator, Linear, Medical |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Daryl Ruff |
| Correspondent | Daryl Ruff ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-04 |
| Decision Date | 1996-04-08 |
| Summary: | summary |