MRIdian Linac System
K-Number: K212958 · 2021-12-14
ApplicantViewray, Incorporated
Decision Date2021-12-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MRIdian Linac System is a medical device manufactured by Viewray, Incorporated. It received FDA 510(k) clearance on 2021-12-14 under approval number K212958. 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 MRIdian Linac System?
MRIdian Linac System is a medical device that received FDA 510(k) clearance on 2021-12-14. It is manufactured by Viewray, Incorporated. The 510(k) number is K212958.
When was MRIdian Linac System approved by the FDA?
MRIdian Linac System received FDA 510(k) clearance on 2021-12-14, under approval number K212958.
What company makes MRIdian Linac System?
MRIdian Linac System is manufactured by Viewray, Incorporated.
What is the FDA product code for MRIdian Linac System?
The FDA product code for 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.