Devices · Varian Medical Systems, Inc.

AI Segmentation

Varian Medical Systems, Inc. is listed for AI Segmentation (K211881). The FDA list gives September 2, 2021 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 MUJ. 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=K211881

Official FDA database record

Date of final decision

September 2, 2021

Company on the FDA list

Varian Medical Systems, Inc.

Lead panel

Radiology

Primary product code

MUJ

openFDA device name for the code

System, Planning, Radiation Therapy Treatment

Device class

2

Regulation number

892.5050

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary