Cleared Traditional

TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)

K232870 · Varian Medical Systems, Inc. · Radiology
Dec 2023
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K232870 is an FDA 510(k) clearance for the TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1), a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on December 21, 2023, 97 days after receiving the submission on September 15, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K232870 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2023
Decision Date December 21, 2023
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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