The following data is part of a premarket notification filed by Varian Medical Systems, Inc with the FDA for Aria Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8).
| Device ID | K221448 |
| 510k Number | K221448 |
| Device Name: | ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) |
| Classification | Accelerator, Linear, Medical |
| Applicant | Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 |
| Contact | Peter J. Coronado |
| Correspondent | Peter J. Coronado Varian Medical Systems, Inc 3100 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 | 2022-05-18 |
| Decision Date | 2022-06-15 |