FDA 510(k)

AccuContour

K-Number: K191928 · 2020-02-28

ApplicantXiamen Manteia Technology , Ltd.

Decision Date2020-02-28

Product CodeQKB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AccuContour is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Manteia Technology , Ltd.. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K191928. 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 AccuContour?

AccuContour is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Xiamen Manteia Technology , Ltd.. The 510(k) number is K191928.

When did AccuContour receive FDA 510(k) clearance?

AccuContour received FDA 510(k) clearance on 2020-02-28, under 510(k) number K191928.

Who is the listed applicant for AccuContour?

The FDA 510(k) record lists Xiamen Manteia Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccuContour?

The FDA product code for AccuContour is QKB.

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 Systems K260528OncoStudioOncosoft. Inc.,K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.K253270Contour ProtégéAI+Mim Software, Inc.

Official Source

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