iDMS Data Management System
K-Number: K161144 · 2016-06-24
ApplicantAccuray Incorporated
Decision Date2016-06-24
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
iDMS Data Management System is a medical device manufactured by Accuray Incorporated. It received FDA 510(k) clearance on 2016-06-24 under approval number K161144. 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 iDMS Data Management System?
iDMS Data Management System is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Accuray Incorporated. The 510(k) number is K161144.
When was iDMS Data Management System approved by the FDA?
iDMS Data Management System received FDA 510(k) clearance on 2016-06-24, under approval number K161144.
What company makes iDMS Data Management System?
iDMS Data Management System is manufactured by Accuray Incorporated.
What is the FDA product code for iDMS Data Management System?
The FDA product code for iDMS Data Management 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.