The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Ai Segmentation.
| Device ID | K211881 |
| 510k Number | K211881 |
| Device Name: | AI Segmentation |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 |
| Contact | Peter Coronado |
| Correspondent | Peter Coronado Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2021-09-02 |