Cleared Traditional

Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)

K232923 · Varian Medical Systems, Inc. · Radiology
Apr 2024
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K232923 is an FDA 510(k) clearance for the Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0), 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 April 30, 2024, 224 days after receiving the submission on September 19, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K232923 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2023
Decision Date April 30, 2024
Days to Decision 224 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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