AccuContour 4.0— 510(k) K251351

Substantially Equivalent

Manteia Technologies Co., Ltd.

FDA 510(k) clearance K251351 for AccuContour 4.0, Substantially Equivalent on 2026-01-23. Applicant: Manteia Technologies Co., Ltd..

Clearance details

Applicant: Manteia Technologies Co., Ltd.
Product code: Code QKB
Advisory panel: Radiology
Date received: 2025-04-30
Decision date: 2026-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, CN

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