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FDA 510(k)

TrueBeam, TrueBeam STx, Edge

K-Number: K171733 · 2017-07-12

ApplicantVarian Medical Systems, Inc.
Decision Date2017-07-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TrueBeam, TrueBeam STx, Edge is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-07-12 under approval number K171733. 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 TrueBeam, TrueBeam STx, Edge?

TrueBeam, TrueBeam STx, Edge is a medical device that received FDA 510(k) clearance on 2017-07-12. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K171733.

When was TrueBeam, TrueBeam STx, Edge approved by the FDA?

TrueBeam, TrueBeam STx, Edge received FDA 510(k) clearance on 2017-07-12, under approval number K171733.

What company makes TrueBeam, TrueBeam STx, Edge?

TrueBeam, TrueBeam STx, Edge is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for TrueBeam, TrueBeam STx, Edge?

The FDA product code for TrueBeam, TrueBeam STx, Edge 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.

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