The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Ai Segmentation.
| Device ID | K203469 |
| 510k Number | K203469 |
| 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 | 2020-11-25 |
| Decision Date | 2021-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856100006233 | K203469 | 000 |
| 00856100006172 | K203469 | 000 |