The following data is part of a premarket notification filed by Adac Laboratories with the FDA for P3imrt Tm.
| Device ID | K002237 |
| 510k Number | K002237 |
| Device Name: | P3IMRT TM |
| 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 | 2000-07-24 |
| Decision Date | 2001-02-02 |