The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Truebeam.
Device ID | K123291 |
510k Number | K123291 |
Device Name: | TRUEBEAM |
Classification | Accelerator, Linear, Medical |
Applicant | VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 |
Contact | Vy Tran |
Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-22 |
Decision Date | 2012-12-20 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TRUEBEAM 87122365 not registered Dead/Abandoned |
Mo Huiqing 2016-08-01 |
TRUEBEAM 77831919 4158172 Live/Registered |
Varian Medical Systems, Inc. 2009-09-22 |
TRUEBEAM 74222120 1784779 Dead/Cancelled |
BELDEN INC. 1991-11-18 |