The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Truebeam, Truebeam Stx, Edge, Vitalbeam.
| Device ID | K213977 |
| 510k Number | K213977 |
| Device Name: | TrueBeam, TrueBeam STx, Edge, VitalBeam |
| Classification | Accelerator, Linear, Medical |
| Applicant | Varian Medical Systems, Inc. 911 Hansen Way Palo Alto, CA 94304 |
| Contact | Peter J. Coronado |
| Correspondent | Peter J. Coronado Varian Medical Systems, Inc. 911 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 | 2021-12-20 |
| Decision Date | 2022-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00899475002363 | K213977 | 000 |
| 00899475002356 | K213977 | 000 |
| 00899475002349 | K213977 | 000 |