The following data is part of a premarket notification filed by Viewray Incorporated with the FDA for The Viewray (mridian) Linac System.
| Device ID | K162393 |
| 510k Number | K162393 |
| Device Name: | The ViewRay (MRIdian) Linac System |
| Classification | Accelerator, Linear, Medical |
| Applicant | VIEWRAY INCORPORATED 2 THERMO FISHER WAY Oakwood Village, OH 44146 |
| Contact | Sean Delaney |
| Correspondent | Sean Delaney VIEWRAY INCORPORATED 2 THERMO FISHER WAY Oakwood Village, OH 44146 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-26 |
| Decision Date | 2017-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868029000360 | K162393 | 000 |
| 00868029000353 | K162393 | 000 |
| 00868029000315 | K162393 | 000 |
| 00868029000308 | K162393 | 000 |