MRIdian Linac System with 138-leaf Collimator
K-Number: K170751 · 2017-06-07
ApplicantViewray, Incorporated
Decision Date2017-06-07
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MRIdian Linac System with 138-leaf Collimator is a medical device manufactured by Viewray, Incorporated. It received FDA 510(k) clearance on 2017-06-07 under approval number K170751. 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 with 138-leaf Collimator?
MRIdian Linac System with 138-leaf Collimator is a medical device that received FDA 510(k) clearance on 2017-06-07. It is manufactured by Viewray, Incorporated. The 510(k) number is K170751.
When was MRIdian Linac System with 138-leaf Collimator approved by the FDA?
MRIdian Linac System with 138-leaf Collimator received FDA 510(k) clearance on 2017-06-07, under approval number K170751.
What company makes MRIdian Linac System with 138-leaf Collimator?
MRIdian Linac System with 138-leaf Collimator is manufactured by Viewray, Incorporated.
What is the FDA product code for MRIdian Linac System with 138-leaf Collimator?
The FDA product code for MRIdian Linac System with 138-leaf Collimator 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.