K243647

Substantially Equivalent

Synapse PACS (7.5)

Applicant: FUJIFILM Healthcare Americas Corporation
Product code: QIH
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 ↗

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