K232113
- 510(k) number
- K232113
- Device name
- Halcyon, Ethos Radiotherapy System
- Applicant
- Varian Medical Systems, Inc. CA · US
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2023-11-03
- Date received
- 2023-07-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232113.pdf
Official FDA record: K232113
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.