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FDA 510(k)

TrueBeam-TrueBeam STx-Edge

K-Number: K162472 · 2017-01-19

ApplicantVarian Medical Systems, Inc.
Decision Date2017-01-19
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 2017-01-19 under 510(k) number K162472. 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 2017-01-19. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K162472.

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

TrueBeam-TrueBeam STx-Edge received FDA 510(k) clearance on 2017-01-19, under 510(k) number K162472.

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.

Other records listing Varian Medical Systems, Inc. as applicant

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Related Devices (Code: IYE)

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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