Company profile

FUJIFILM Healthcare Americas Corporation

FUJIFILM Healthcare Americas Corporation has 3 AI-enabled medical devices on the FDA list. The first decision was on May 3, 2024 and the most recent on June 18, 2026 (Synapse PACS (7.6.0)). Its most common review panel is Radiology (3 devices).

3AI devices

2024First decision

2026Latest decision

1Specialties

Per year

202420252026

FUJIFILM Healthcare Americas Corporation AI devices per year: 2024 1, 2025 1, 2026 1

By specialty

Radiology3

Related guides

Top radiology devices

Timeline

June 18, 2026 · 510(k) K261713Synapse PACS (7.6.0) · Radiology · QIH
June 30, 2025 · 510(k) K243647Synapse PACS (7.5) · Radiology · QIH
May 3, 2024 · 510(k) K233687ECHELON Synergy V10.0 · Radiology · LNH