Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon

Varian Medical Systems, Inc. · K192377 · 2020-02-10

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon is an AI-enabled medical device from Varian Medical Systems, Inc., listed by FDA (510(k), K192377) with a decision date of 2020-02-10. Review panel: Radiology.

FDA submission numberK192377
Pathway510(k)
CompanyVarian Medical Systems, Inc.
Review panel (specialty)Radiology
FDA decision date2020-02-10
DecisionSubstantially Equivalent
Product codeIYE
ClassificationAccelerator, Linear, Medical
Device class2
Regulation number892.5050
Review time (calendar days)164
Applicant countryUS

Official FDA database record · FDA AI-enabled device list

More devices from Varian Medical Systems, Inc. · All Radiology AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.