FDA · official record K232870Substantially Equivalent

TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)

Name: TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) — FDA K232870
Creator: Varian Medical Systems, Inc.
Keywords: TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1), TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1), K232870, IYE, FDA

United StatesIYEVarian Medical Systems, Inc.

Verified

Official record identity

FDA application number: K232870
Decision date: December 21, 2023
Published decision: Substantially Equivalent

Classification

Product code: IYE

Published parties

Applicant: Varian Medical Systems, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2023-09-15
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.5050

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.