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FDA 510(k)

TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)

K-Number: K232870 · 2023-12-21

ApplicantVarian Medical Systems, Inc.
Decision Date2023-12-21
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) 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 2023-12-21 under 510(k) number K232870. 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 and VitalBeam (4.1)?

TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K232870.

When did TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) receive FDA 510(k) clearance?

TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) received FDA 510(k) clearance on 2023-12-21, under 510(k) number K232870.

Who is the listed applicant for TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)?

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 and VitalBeam (4.1)?

The FDA product code for TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) 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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