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.

Summary

FUJIFILM Healthcare Americas' Synapse PACS (7.6.0) is filed under QIH, automated radiological image processing software. The record doesn't expand "PACS" or describe the processing the software performs.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It was a Special 510(k).

FUJIFILM filed from Lexington, Massachusetts. The decision came 27 calendar days after receipt (May 22 to June 18, 2026).

Clearance details

Applicant: FUJIFILM Healthcare Americas Corporation
Product code: Product 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.