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FDA 510(k)

AutoContour (RADAC V5)

K-Number: K260509 · 2026-03-19

ApplicantRadformation, Inc.
Decision Date2026-03-19
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AutoContour (RADAC V5) is a medical device manufactured by Radformation, Inc.. It received FDA 510(k) clearance on 2026-03-19 under approval number K260509. 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 AutoContour (RADAC V5)?

AutoContour (RADAC V5) is a medical device that received FDA 510(k) clearance on 2026-03-19. It is manufactured by Radformation, Inc.. The 510(k) number is K260509.

When was AutoContour (RADAC V5) approved by the FDA?

AutoContour (RADAC V5) received FDA 510(k) clearance on 2026-03-19, under approval number K260509.

What company makes AutoContour (RADAC V5)?

AutoContour (RADAC V5) is manufactured by Radformation, Inc..

What is the FDA product code for AutoContour (RADAC V5)?

The FDA product code for AutoContour (RADAC V5) is QKB.

Other Devices by Radformation, Inc.

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Related Devices (Code: QKB)

K181572Workflow BoxMirada Medical, Ltd. K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. K200323AutoContourRadformation, Inc. K193252Contour ProtegeAIMim Software, Inc. K191928AccuContourXiamen Manteia Technology , Ltd. K213628VBrainVysioneer, 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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