510(k) · Radiology

AI Segmentation

by Varian Medical Systems, Inc.

AI Segmentation is an AI-enabled medical device from Varian Medical Systems, Inc. that the U.S. FDA cleared through 510(k) K211881 on September 2, 2021. Its lead review panel is Radiology and its primary product code is MUJ (System, Planning, Radiation Therapy Treatment).

See also FDA-cleared AI radiology devices in 2021, all FDA AI clearances in 2021, top radiology AI devices.

Key facts

Submission numberK211881
Pathway510(k)
Date of final decision
Company (FDA list)Varian Medical Systems, Inc.
Lead review panelRadiology
Primary product codeMUJ — System, Planning, Radiation Therapy Treatment
Applicant (openFDA)Varian Medical Systems, Inc.
Applicant locationPalo Alto, CA, US
Device classClass 2
Regulation number21 CFR 892.5050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. AI Segmentation went through this pathway (K211881).

openFDA lists it as a Class 2 device under 21 CFR 892.5050. Class II devices are moderate risk and are subject to general and special controls.

Product code MUJ covers 33 devices on the FDA AI list. By decision date, this device is #11 of 33 under that code. Varian Medical Systems, Inc. has 5 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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