The ViewRay (MRIdian) Linac System
K-Number: K162393 · 2017-02-24
ApplicantViewray, Incorporated
Decision Date2017-02-24
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
The ViewRay (MRIdian) Linac System is a medical device manufactured by Viewray, Incorporated. It received FDA 510(k) clearance on 2017-02-24 under approval number K162393. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the The ViewRay (MRIdian) Linac System?
The ViewRay (MRIdian) Linac System is a medical device that received FDA 510(k) clearance on 2017-02-24. It is manufactured by Viewray, Incorporated. The 510(k) number is K162393.
When was The ViewRay (MRIdian) Linac System approved by the FDA?
The ViewRay (MRIdian) Linac System received FDA 510(k) clearance on 2017-02-24, under approval number K162393.
What company makes The ViewRay (MRIdian) Linac System?
The ViewRay (MRIdian) Linac System is manufactured by Viewray, Incorporated.
What is the FDA product code for The ViewRay (MRIdian) Linac System?
The FDA product code for The ViewRay (MRIdian) Linac System is IYE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.