Cleared Traditional

Halcyon, Ethos Radiotherapy System

K232113 · Varian Medical Systems, Inc. · Radiology
Nov 2023
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K232113 is an FDA 510(k) clearance for the Halcyon, Ethos Radiotherapy System, 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 November 3, 2023, 112 days after receiving the submission on July 14, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K232113 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2023
Decision Date November 03, 2023
Days to Decision 112 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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