The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Peregrine Radiation Therapy Dose Calculation System.
| Device ID | K993675 |
| 510k Number | K993675 |
| Device Name: | PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
| Contact | Francis X Dobscha |
| Correspondent | Francis X Dobscha NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-01 |
| Decision Date | 2000-09-05 |
| Summary: | summary |