Medical Device Manufacturer · JP , Ashigara Kami-Gun

Fujifilm Corporation - FDA 510(k) Cleared Devices

63 submissions · 63 cleared · Since 2018

Recent clearances: Synapse Lung Nodule AI, Synapse 3D Base Tools (V7.2), APERTO Lucent MRI System

63

Total

63

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fujifilm Corporation Radiology ✕

19 devices

1-12 of 19

Cleared May 27, 2026

Synapse Lung Nodule AI

Radiology · 160d

Cleared Apr 30, 2026

Synapse 3D Base Tools (V7.2)

Radiology · 128d

Cleared Apr 06, 2026

APERTO Lucent MRI System

Radiology · 124d

Cleared Sep 17, 2025

ECHELON Synergy

Radiology · 135d

Cleared May 21, 2025

Synapse 3D Base Tools (V7.0)

Radiology · 166d

Cleared May 20, 2025

SCENARIA View Phase 5.0

Radiology · 99d

Cleared Nov 10, 2022

Synapse 3D Base Tools v6.6

Radiology · 154d

Cleared Jun 03, 2022

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2

Radiology · 157d

Cleared May 27, 2022

Aspire Cristalle

Radiology · 260d

Cleared Nov 08, 2021

FDR Cross (DR-XD 3000)

Radiology · 53d

Cleared Feb 09, 2021

Synapse 3D, Synapse 3D Base Tools v6.1

Radiology · 118d

Cleared Apr 10, 2020

DR-ID 1200SDK System

Radiology · 28d