Synapse PACS (7.5)— 510(k) K243647

Name: FDA 510(k) clearance K243647
Creator: U.S. Food and Drug Administration
Published: 2025-06-30

Substantially Equivalent

FUJIFILM Healthcare Americas Corporation

FDA 510(k) clearance K243647 for Synapse PACS (7.5), Substantially Equivalent on 2025-06-30. Applicant: FUJIFILM Healthcare Americas Corporation. Device class: 2.

Clearance details

Applicant: FUJIFILM Healthcare Americas Corporation
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-11-26
Decision date: 2025-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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