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FDA 510(k)

AutoContour

K-Number: K200323 · 2020-10-30

ApplicantRadformation, Inc.
Decision Date2020-10-30
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AutoContour is the device name listed in this FDA 510(k) record. The listed applicant is Radformation, Inc.. It received FDA 510(k) clearance on 2020-10-30 under 510(k) number K200323. 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?

AutoContour is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Radformation, Inc.. The 510(k) number is K200323.

When did AutoContour receive FDA 510(k) clearance?

AutoContour received FDA 510(k) clearance on 2020-10-30, under 510(k) number K200323.

Who is the listed applicant for AutoContour?

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

What is the FDA product code for AutoContour?

The FDA product code for AutoContour is QKB.

Other records listing Radformation, Inc. as applicant

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)K253962ClearCheck (RADCC V2.7)K260509AutoContour (RADAC V5)K252988ChartCheck (RADCH V1.6)K252863ClearCalc Model RADCA V2.6K242729AutoContour (Model RADAC V4)

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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.K261306AI Contouring (VA10A)Varian Medical SystemsK260528OncoStudioOncosoft. Inc.,K252548AI-Rad Companion Organs RTSiemens Healthcare GmbHK252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.K253270Contour ProtégéAI+Mim Software, 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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