Fujifilm Corporation - FDA 510(k) Cleared Devices
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
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
Cleared
Nov 12, 2019
FDR D-EVO III flat panel detector system
Radiology
26d
Cleared
Nov 01, 2019
FDR SE Lite
Radiology
56d
Cleared
Oct 18, 2019
Synapse 3D Blood Flow Analysis
Radiology
129d
Cleared
Jul 03, 2019
Biopsy Positioner
Radiology
28d
Cleared
Apr 25, 2019
Synapse Enterprise Viewer Version 1.0
Radiology
155d
Cleared
Mar 26, 2019
Synapse PACS
Radiology
48d
Cleared
Sep 25, 2018
Synapse 3D Optional Tools
Radiology
84d