The following data is part of a premarket notification filed by Best Nomos with the FDA for Corvus Radiation Therapy Planning System.
Device ID | K211034 |
510k Number | K211034 |
Device Name: | Corvus Radiation Therapy Planning System |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | Best Nomos One Best Drive Pittsburgh, PA 15202 |
Contact | Vineet Gupta |
Correspondent | Vineet Gupta 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 | 2021-04-07 |
Decision Date | 2021-05-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00852656007502 | K211034 | 000 |