Medical Device Manufacturer · US , Lexington , MA

Fujifilm Healthcare Americas Corporation - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2023

Recent clearances: FUJIFILM Stiffening Wire Device (SW-2000), Synapse PACS (7.5), Double Balloon Endoscope EN-840T, Over-tube TS-1214C

13

Total

13

Cleared

0

Denied

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

8 devices

1-8 of 8

Cleared Jun 18, 2026

Synapse PACS (7.6.0)

Radiology · 27d

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

Radiology · 143d

Cleared Oct 12, 2023

Scenaria View 4.2

Radiology · 134d