The following data is part of a premarket notification filed by Best Nomos with the FDA for Corvus Radiation Therapy Planning System.
Device ID | K100092 |
510k Number | K100092 |
Device Name: | CORVUS RADIATION THERAPY PLANNING SYSTEM |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | BEST NOMOS ONE BEST DRIVE Pittsburgh, PA 15202 |
Contact | Chi Palko |
Correspondent | Chi Palko BEST NOMOS ONE BEST DRIVE Pittsburgh, PA 15202 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-01-13 |
Decision Date | 2010-02-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00852656007427 | K100092 | 000 |
00852656007410 | K100092 | 000 |
00852656007045 | K100092 | 000 |
00852656007038 | K100092 | 000 |