ARTAssistant— 510(k) K250780

Substantially Equivalent

Manteia Technologies Co., Ltd.

FDA 510(k) clearance K250780 for ARTAssistant, Substantially Equivalent on 2025-12-05. Applicant: Manteia Technologies Co., Ltd..

Clearance details

Applicant: Manteia Technologies Co., Ltd.
Product code: Code QKB
Advisory panel: Radiology
Date received: 2025-03-14
Decision date: 2025-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, CN

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