The following data is part of a premarket notification filed by Viewray Incorporated with the FDA for Mridian Linac System With 138-leaf Collimator.
| Device ID | K170751 |
| 510k Number | K170751 |
| Device Name: | MRIdian Linac System With 138-leaf Collimator |
| 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 | 2017-03-13 |
| Decision Date | 2017-06-07 |
| Summary: | summary |