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FDA 510(k)

AI Contouring (VA10A)

K-Number: K261306 · 2026-07-10

ApplicantVarian Medical Systems
Decision Date2026-07-10
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI Contouring (VA10A) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K261306. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI Contouring (VA10A)?

AI Contouring (VA10A) is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is Varian Medical Systems. The 510(k) number is K261306.

When did AI Contouring (VA10A) receive FDA 510(k) clearance?

AI Contouring (VA10A) received FDA 510(k) clearance on 2026-07-10, under 510(k) number K261306.

Who is the listed applicant for AI Contouring (VA10A)?

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

What is the FDA product code for AI Contouring (VA10A)?

The FDA product code for AI Contouring (VA10A) is QKB.

Other records listing Varian Medical Systems as applicant

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Related Devices (Code: QKB)

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.

K262452AutoContour (RADAC V6)Radformation, Inc.K260528OncoStudioOncosoft. Inc.,K252548AI-Rad Companion Organs RTSiemens Healthcare GmbHK252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.K253270Contour ProtégéAI+Mim Software, Inc.K260509AutoContour (RADAC V5)Radformation, 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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