The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Truebeam, Truebeam Stx, Edge.
| Device ID | K171733 |
| 510k Number | K171733 |
| Device Name: | TrueBeam, TrueBeam STx, Edge |
| Classification | Accelerator, Linear, Medical |
| Applicant | Varian Medical Systems, Inc. 911 Hansen Way Palo Alto, CA 94304 |
| Contact | Sara Muddell |
| Correspondent | Sara Muddell Varian Medical Systems, Inc. 911 Hansen Way Palo Alto, CA 94304 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-12 |
| Decision Date | 2017-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00899475002233 | K171733 | 000 |
| 00858086006658 | K171733 | 000 |
| 00858086006665 | K171733 | 000 |
| 00858086006672 | K171733 | 000 |
| 00858086006689 | K171733 | 000 |
| 00858086006696 | K171733 | 000 |
| 00858086006702 | K171733 | 000 |
| 00858086006719 | K171733 | 000 |
| 00858086006726 | K171733 | 000 |
| 00858086006733 | K171733 | 000 |
| 00858086006740 | K171733 | 000 |
| 00858086006757 | K171733 | 000 |
| 00858086006764 | K171733 | 000 |
| 00899475002257 | K171733 | 000 |
| 00858086006641 | K171733 | 000 |