The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Adac Pinnacle3tm Radiation Therapy Planning System.
| Device ID | K993923 |
| 510k Number | K993923 |
| Device Name: | ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Janice E Brown |
| Correspondent | Janice E Brown ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-18 |
| Decision Date | 2000-04-07 |
| Summary: | summary |