The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Raptor Treatment Planning System.
Device ID | K993359 |
510k Number | K993359 |
Device Name: | RAPTOR TREATMENT PLANNING SYSTEM |
Classification | Accelerator, Linear, Medical |
Applicant | NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
Contact | William O Chishko |
Correspondent | William O Chishko NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-06 |
Decision Date | 1999-12-21 |
Summary: | summary |