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FDA 510(k)

AI Segmentation

K-Number: K211881 · 2021-09-02

ApplicantVarian Medical Systems, Inc.
Decision Date2021-09-02
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI Segmentation is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-09-02 under approval number K211881. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI Segmentation?

AI Segmentation is a medical device that received FDA 510(k) clearance on 2021-09-02. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K211881.

When was AI Segmentation approved by the FDA?

AI Segmentation received FDA 510(k) clearance on 2021-09-02, under approval number K211881.

What company makes AI Segmentation?

AI Segmentation is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for AI Segmentation?

The FDA product code for AI Segmentation is MUJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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