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FDA 510(k)

AccuContour

K-Number: K221706 · 2023-03-09

ApplicantManteia Technologies Co., Ltd.
Decision Date2023-03-09
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AccuContour is a medical device manufactured by Manteia Technologies Co., Ltd.. It received FDA 510(k) clearance on 2023-03-09 under approval 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. It is manufactured by Manteia Technologies Co., Ltd.. The 510(k) number is K221706.

When was AccuContour approved by the FDA?

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

What company makes AccuContour?

AccuContour is manufactured by Manteia Technologies Co., Ltd..

What is the FDA product code for AccuContour?

The FDA product code for AccuContour is QKB.

Other Devices by Manteia Technologies Co., Ltd.

K223834AccuCheck K223724MOZI TPS K250780ARTAssistant K250696AccuCheck K251351AccuContour 4.0

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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