Cleared Traditional

Halcyon, Ethos Radiotherapy System (5.0)

K252977 · Varian Medical Systems, Inc. · Radiology
Jan 2026
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K252977 is an FDA 510(k) clearance for the Halcyon, Ethos Radiotherapy System (5.0), 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 January 21, 2026, 126 days after receiving the submission on September 17, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K252977 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2025
Decision Date January 21, 2026
Days to Decision 126 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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