The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Ethos Treatment Management, Ethos Treatment Planning.
| Device ID | K212294 |
| 510k Number | K212294 |
| Device Name: | Ethos Treatment Management, Ethos Treatment Planning |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-22 |
| Decision Date | 2021-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856100006271 | K212294 | 000 |
| 00856100006264 | K212294 | 000 |