The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Aria Radiation Therapy Management.
| Device ID | K173838 |
| 510k Number | K173838 |
| Device Name: | ARIA Radiation Therapy Management |
| 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 | 2017-12-18 |
| Decision Date | 2018-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856100006110 | K173838 | 000 |
| 00856100006097 | K173838 | 000 |
| 00856100006127 | K173838 | 000 |
| 00856806006049 | K173838 | 000 |
| 00856100006073 | K173838 | 000 |
| 00856100006066 | K173838 | 000 |
| 00856100006165 | K173838 | 000 |
| 00856100006189 | K173838 | 000 |