Fujifilm Healthcare Americas Corporation - FDA 510(k) Cleared Devices
12
Total
12
Cleared
0
Denied
FDA 510(k) cleared devices by Fujifilm Healthcare Americas Corporation Radiology ✕
7 devices
Cleared
Jun 30, 2025
Synapse PACS (7.5)
Radiology
216d
Cleared
May 10, 2024
APERTO Lucent MRI System
Radiology
179d
Cleared
May 03, 2024
ECHELON Synergy V10.0
Radiology
168d
Cleared
Apr 26, 2024
FCT iSTREAM Phase 1
Radiology
171d
Cleared
Dec 13, 2023
Endoscopic Ultrasonic Probe (P2612S-L)
Radiology
189d
Cleared
Nov 20, 2023
ARIETTA x10
Radiology
143d
Cleared
Oct 12, 2023
Scenaria View 4.2
Radiology
134d