Synapse 3D Base Tools (V7.2)— 510(k) K254189

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K254189 for Synapse 3D Base Tools (V7.2), Substantially Equivalent on 2026-04-30. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-12-23
Decision date: 2026-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minato-Ku, Tokyo, JP

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