The following data is part of a premarket notification filed by Viewray, Incorporated with the FDA for Mridian Linac System.
Device ID | K181989 |
510k Number | K181989 |
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 | 2018-07-26 |
Decision Date | 2019-02-20 |
Summary: | summary |