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FDA 510(k)

AccuContour 4.0

K-Number: K251351 · 2026-01-23

ApplicantManteia Technologies Co., Ltd.
Decision Date2026-01-23
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AccuContour 4.0 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 2026-01-23 under 510(k) number K251351. 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 4.0?

AccuContour 4.0 is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Manteia Technologies Co., Ltd.. The 510(k) number is K251351.

When did AccuContour 4.0 receive FDA 510(k) clearance?

AccuContour 4.0 received FDA 510(k) clearance on 2026-01-23, under 510(k) number K251351.

Who is the listed applicant for AccuContour 4.0?

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 4.0?

The FDA product code for AccuContour 4.0 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.

K250780ARTAssistantK250696AccuCheckK223834AccuCheckK223724MOZI TPSK221706AccuContour

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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