FUJIFILM Healthcare Americas Corporation

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

3 AI-enabled medical devices from FUJIFILM Healthcare Americas Corporation on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2026-06-18	K261713	Synapse PACS (7.6.0)	FUJIFILM Healthcare Americas Corporation	Radiology
2025-06-30	K243647	Synapse PACS (7.5)	FUJIFILM Healthcare Americas Corporation	Radiology
2024-05-03	K233687	ECHELON Synergy V10.0	Fujifilm Healthcare Americas Corporation	Radiology

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