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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 a medical device manufactured by Manteia Technologies Co., Ltd.. It received FDA 510(k) clearance on 2026-01-23 under approval 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. It is manufactured by Manteia Technologies Co., Ltd.. The 510(k) number is K251351.

When was AccuContour 4.0 approved by the FDA?

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

What company makes AccuContour 4.0?

AccuContour 4.0 is manufactured by Manteia Technologies Co., Ltd..

What is the FDA product code for AccuContour 4.0?

The FDA product code for AccuContour 4.0 is QKB.

Other Devices by Manteia Technologies Co., Ltd.

K223834AccuCheck K223724MOZI TPS K221706AccuContour K250780ARTAssistant K250696AccuCheck

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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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