FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa

FDA Device Registration & Listing · KASHIWA-SHI Chiba, JP · Registration 3018423337

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3018423337
FEI Number
3018423337
Entity Name
FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa
City/State/Country
KASHIWA-SHI Chiba, JP
Establishment Address
2-1, SHINTOYOFUTA, KASHIWA-SHI Chiba 277-0804, JP
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
FUJIFILM Corporation (Owner Number: 10081521)
Owner / Operator Contact Address
26-30, Nishiazabu 2-chome, Minato-ku, JP-13 106-8620, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K080062
PMA Number
N/A

All Registered Proprietary Names

OASIS MRI System OASIS Velocity MRI System SCENARIA View OASIS MRI System ECHELON OVAL MRI SYSTEM APERTO Lucent MRI System OASIS CTL Coil, OASIS OD Flexible Body Coil (L AND XL), OASIS Rapid Foot Coil ECHELON Synergy MRI System Supria Whole-Body X-Ray CT System ECHELON OVAL MRI SYSTEM SCENARIA View SCENARIA View Phase 5 OASIS Rapid Breast Coil, Oasis Rapid NV Coil

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-05-31
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2021-11-18
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-05-31
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2021-04-24
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2021-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2021-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-05-13
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2021-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-08-15
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-06-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-01-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2021-04-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-05-22
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2021-04-24

Official Correspondent

No official correspondent registered.

US Agent Details

Randy Vader Business: FUJIFILM Healthcare Americas Corporation Email: randy.vader@fujifilm.com Phone: (360) 3566821

Related Public Records

Same Entity

FUJIFILM Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3019784575 FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji KOKUBUNJI-SHI Tokyo, JP
3032109225 FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office Kashiwa-shi Chiba, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033504 General Electric Co. GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM 2003-11-25
K013636 GE Medical Systems SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 2002-01-24
K250443 Siemens Healthcare GmbH MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile 2025-06-16
K151015 Hitachi Medical Systems America, Inc. ECHELON Oval V 5.0 MRI System 2015-07-29
K910715 Philips Medical Systems (Cleveland), Inc. VISTA HPQ SYSTEM 1991-06-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0029-2007 Hitachi Medical Systems America Inc 2
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014 Philips Medical Systems (Cleveland) Inc 2
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024 Philips North America Llc 2
Achieva 1.5T
Z-0390-2024 Philips North America Llc 2
Achieva 1.5T Conversion
Z-0391-2024 Philips North America Llc 2
Achieva 1.5T Initial System

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018423337. Last updated year: 2026. Please use registration number 3018423337 when referencing this establishment in official correspondence.
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