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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 the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-09-02 under 510(k) 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. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K211881.

When did AI Segmentation receive FDA 510(k) clearance?

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

Who is the listed applicant for AI Segmentation?

The FDA 510(k) record lists Varian Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI Segmentation?

The FDA product code for AI Segmentation is MUJ.

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Related Devices (Code: MUJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.

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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