Medical Device Manufacturer · US , Lexington , MA

Fujifilm Healthcare Americas Corporation

12 submissions · 12 cleared · Since 2023
12
Total
12
Cleared
0
Denied

Fujifilm Healthcare Americas Corporation — FDA 510(k) Submissions

Fujifilm Healthcare Americas Corporation has submitted 12 FDA 510(k) premarket notifications since 2023, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enteroscope And Accessories, System, Nuclear Magnetic Resonance Imaging, System, X-ray, Tomography, Computed, Transducer, Ultrasonic, Diagnostic, System, Imaging, Pulsed Doppler, Ultrasonic . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
FUJIFILM Stiffening Wire Device (SW-2000)
K251204 · FDA Enteroscope And Accessories · Gastroenterology & Urology
Sep 2025 161d
Synapse PACS (7.5)
K243647 · QIH Automated Radiological... · Radiology
Jun 2025 216d
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
K233321 · FDA Enteroscope And Accessories · Gastroenterology & Urology
Jun 2024 258d
APERTO Lucent MRI System
K233629 · LNH System, Nuclear Magnetic... · Radiology
May 2024 179d
ECHELON Synergy V10.0
K233687 · LNH System, Nuclear Magnetic... · Radiology
May 2024 168d
FCT iSTREAM Phase 1
K233583 · JAK System, X-ray,... · Radiology
Apr 2024 171d
FUJIFILM Endoscope Model EB-710XT
K240075 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Feb 2024 28d
Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
K231666 · ITX Transducer, Ultrasonic,... · Radiology
Dec 2023 189d
ARIETTA x10
K231941 · IYN System, Imaging, Pulsed... · Radiology
Nov 2023 143d
Scenaria View 4.2
K231574 · JAK System, X-ray,... · Radiology
Oct 2023 134d
Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
K230752 · FED Endoscopic Access... · Gastroenterology & Urology
Sep 2023 182d
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
K232314 · FDS Gastroscope And... · Gastroenterology & Urology
Sep 2023 30d
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All12 Radiology 7 Gastroenterology & Urology 4 Ear, Nose, Throat 1