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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 a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-12-21 under approval 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. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K232870.

When was TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) approved by the FDA?

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

What company makes TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)?

TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) is manufactured by Varian Medical Systems, Inc..

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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