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

510(k)K232923RadiologyIYE

Varian Medical Systems Inc. is listed for Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) (K232923). The FDA list gives April 30, 2024 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is IYE. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232923

Official FDA database record

Date of final decision: April 30, 2024
Company on the FDA list: Varian Medical Systems Inc.
Lead panel: Radiology
Primary product code: IYE
openFDA device name for the code: Accelerator, Linear, Medical
Device class: 2
Regulation number: 892.5050
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary