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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 Clinical Trials

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.

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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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