The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Truebeam.
| Device ID | K111106 |
| 510k Number | K111106 |
| 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 | 2011-04-20 |
| Decision Date | 2011-08-18 |
| 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 |