The following data is part of a premarket notification filed by Varian Medical Systems with the FDA for Verification Console.
Device ID | K124002 |
510k Number | K124002 |
Device Name: | VERIFICATION CONSOLE |
Classification | System, Radiation Therapy, Charged-particle, Medical |
Applicant | VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY Palo Alto, CA 94304 -1034 |
Contact | Peter J Coronado |
Correspondent | Peter J Coronado VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY Palo Alto, CA 94304 -1034 |
Product Code | LHN |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-26 |
Decision Date | 2013-02-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00856104006024 | K124002 | 000 |
00856104006123 | K124002 | 000 |
00856104006079 | K124002 | 000 |