510(k) K232923

Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) by Varian Medical Systems, Inc. — Product Code IYE

K232923 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)". The FDA issued a decision of Substantially Equivalent on April 30, 2024. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Varian Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2024
Date Received
September 19, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type