The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Velocity.
Device ID | K173636 |
510k Number | K173636 |
Device Name: | Velocity |
Classification | System, Image Processing, Radiological |
Applicant | Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 |
Contact | Peter J. Coronado |
Correspondent | Peter J. Coronado Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-24 |
Decision Date | 2018-02-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00854393006022 | K173636 | 000 |
00854393006015 | K173636 | 000 |
00854393006039 | K173636 | 000 |