The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Vitalbeam.
Device ID | K150706 |
510k Number | K150706 |
Device Name: | VitalBeam |
Classification | Accelerator, Linear, Medical |
Applicant | VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 -1129 |
Contact | Peter J. Coronado |
Correspondent | Peter J. Coronado VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 -1129 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-18 |
Decision Date | 2015-05-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VITALBEAM 86759112 5438663 Live/Registered |
Varian Medical Systems, Inc 2015-09-16 |