Company profile

Fujifilm Corporation

Fujifilm Corporation has 7 AI-enabled medical devices on the FDA list. The first decision was on February 9, 2021 and the most recent on May 27, 2026 (Synapse Lung Nodule AI). Its most common review panel is Radiology (6 devices).

7AI devices

2021First decision

2026Latest decision

2Specialties

Per year

2021202320252026

Fujifilm Corporation AI devices per year: 2021 1, 2023 1, 2025 3, 2026 2

By specialty

Radiology6
Gastroenterology-Urology1

Related guides

Top radiology devices

Timeline

May 27, 2026 · 510(k) K254075Synapse Lung Nodule AI · Radiology · OEB
April 30, 2026 · 510(k) K254189Synapse 3D Base Tools (V7.2) · Radiology · QIH
September 17, 2025 · 510(k) K251386ECHELON Synergy · Radiology · LNH
May 21, 2025 · 510(k) K243762Synapse 3D Base Tools (V7.0) · Radiology · QIH
May 20, 2025 · 510(k) K250370SCENARIA View Phase 5.0 · Radiology · JAK
December 15, 2023 · 510(k) K230751EW10-EC02 Endoscopy Support Program · Gastroenterology-Urology · QNP
February 9, 2021 · 510(k) K203103Synapse 3D, Synapse 3D Base Tools v6.1 · Radiology · LLZ