Synapse 3D Base Tools (V7.0)— 510(k) K243762

Name: FDA 510(k) clearance K243762
Creator: U.S. Food and Drug Administration
Published: 2025-05-21

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K243762 for Synapse 3D Base Tools (V7.0), Substantially Equivalent on 2025-05-21. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-12-06
Decision date: 2025-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minato-Ku, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.