Synapse PACS (7.6.0)— 510(k) K261713

Name: FDA 510(k) clearance K261713
Creator: U.S. Food and Drug Administration
Published: 2026-06-18

Substantially Equivalent

FUJIFILM Healthcare Americas Corporation

FDA 510(k) clearance K261713 for Synapse PACS (7.6.0), Substantially Equivalent on 2026-06-18. 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: 2026-05-22
Decision date: 2026-06-18
Decision: Substantially Equivalent
Clearance type: Special
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.