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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 the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-07-12 under 510(k) 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. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K171733.

When did TrueBeam, TrueBeam STx, Edge receive FDA 510(k) clearance?

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

Who is the listed applicant for TrueBeam, TrueBeam STx, Edge?

The FDA 510(k) record lists Varian Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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