MediAI-BA— 510(k) K250914

Substantially Equivalent

Crescom Co., Ltd.

FDA 510(k) clearance K250914 for MediAI-BA, Substantially Equivalent on 2025-12-18. Applicant: Crescom Co., Ltd..

Clearance details

Applicant: Crescom Co., Ltd.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-03-27
Decision date: 2025-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

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