The following data is part of a premarket notification filed by Viewray, Incorporated with the FDA for Mridian Linac System.
| Device ID | K212958 |
| 510k Number | K212958 |
| Device Name: | MRIdian Linac System |
| Classification | Accelerator, Linear, Medical |
| Applicant | ViewRay, Incorporated 815 E. Middlefield Road Mountain View, CA 94043 |
| Contact | Sean Delaney |
| Correspondent | Sean Delaney ViewRay, Incorporated 815 E. Middlefield Road Mountain View, CA 94043 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-16 |
| Decision Date | 2021-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850036816027 | K212958 | 000 |
| 00868029000391 | K212958 | 000 |
| 00868029000346 | K212958 | 000 |