FDA 510(k)

AccuContour

K-Number: K221706 · 2023-03-09

Decision Date2023-03-09

Product CodeQKB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AccuContour is the device name listed in this FDA 510(k) record. The listed applicant is Manteia Technologies Co., Ltd.. It received FDA 510(k) clearance on 2023-03-09 under 510(k) number K221706. 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 2023-03-09. The listed applicant is Manteia Technologies Co., Ltd.. The 510(k) number is K221706.

When did AccuContour receive FDA 510(k) clearance?

AccuContour received FDA 510(k) clearance on 2023-03-09, under 510(k) number K221706.

Who is the listed applicant for AccuContour?

The FDA 510(k) record lists Manteia Technologies Co., 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.

Other records listing Manteia Technologies Co., Ltd. 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.

K251351AccuContour 4.0 K250780ARTAssistant K250696AccuCheck K223834AccuCheck K223724MOZI TPS

Related Devices (Code: QKB)

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.