K252977
- 510(k) number
- K252977
- Device name
- Halcyon, Ethos Radiotherapy System (5.0)
- Applicant
- Varian Medical Systems, Inc. CA · US
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2026-01-21
- Date received
- 2025-09-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252977.pdf
Official FDA record: K252977
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.