FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office

FDA Device Registration & Listing · Kashiwa-shi Chiba, JP · Registration 3032109225

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
3032109225
FEI Number
3032109225
Entity Name
FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office
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
K073310
PMA Number
N/A

All Registered Proprietary Names

Prosound 75 Supria Whole-Body X-Ray CT System APERTO LUCENT MRI System L44LA ARIETTA Prologue SCENARIA View Prosound F37 ECHELON OVAL MRI SYSTEM ARIETTA 60 / ARIETTA S60 / ARIETTA V60 CL4416R C41L47RP C23 CC41R2 UST-2265-2 L43K C25P VC35 C253 L46K1 S11 C42T R41R C251 L53K L44K UST-2266-5 L52H CL4416R1 VC34 L44LA1 S3ESCLS L31KP L35 VC41V C22K C22P L44LA C41B S31 S121 C252 CC41R S3ESEL L55 L442 C41RP C23RV L441 S42 Aloka Arietta 850 C42 L51K L34 S3ESL1 ARIETTA 850 CC41R1 C42K C41V1 MXS1 R41RL C35 SML44 L64 ECHELON Synergy MRI System FCT iStream Phase 1 OASIS Magnetic Resonance Imaging System ECHELON OVAL MRI SYSTEM Prosound 6 Prosound Alpha 7 L64 S31 VC35 L51K C25P CC41R L55 C41V C35 C23RV/C23 CC41R2 UST-2265-2 L44K L442 VC41V C421 CL4416R1 C41RP C22K L34 C41L47RP C41V1 C253 S11 C22P C41B L43K C253A C42K C251 L53K ARIETTA 50 OASIS Rapid Breast Coil, Oasis Rapid NV Coil APERTO Lucent MRI System UST-5310 and UST-5311 Prosound Alpha 7, ARIETTA 70 ECHELON Synergy UST-5311 CL4416R L44LA1 C251 L64 UST-5310 C41V R41RL CC41R1 L441 L46K1 ARIETTA Precision C22T C42K C22P C25P L43K L44K CC41R2 L44LA C22i CL4416R1 C42T L51K S31KP C41L47RP L53K C42 C35 L441 C421 S3ESL1 S42 L34 S121 S31 S3ESCLS MXS1 UST-2266-5 S3ESEL C251 L64 MXS2ESLL1 UST-2265-2 MXS2ESLL L53K Lisendo 880 C42K SML44 C252 L35 ARIETTA 65 ARIETTA 650 OASIS MRI System C41RP ARIETTA x10 C23RV L31KP L44LA L55 R41R VC35 C35 CC41R2 C421 L53K C41V1 UST-2266-5 C252 S121 S3ESEL L44K L64 C42T CL4416R1 L441 C253 L34 C41RP ARIETTA 50 C42K S11 CC41R L442 C421 L44K VC35 VC41V C253A L64 L53K C41L47RP L51K C35 C22P S31 C23RV/C23 C41B C251 CL4416R1 C22K C25P UST-2265-2 CC41R2 C41V L55 L43K C41V1 R41R C41V1 L46K1 L55 L44K L44LA1 C22I EUP-L53L C41 L53K L442 S121 L43LAP C41B C41V C25P S11 C22P C23 C421 L35 VC35 SML44 C22T L43KM C42K CC41R L64 C253A C42 C253 S3ESL1 L34 L52H C252 MXS1 C35 R41RL S3ESEL C22K ARIETTA 750 L31KP C41L47RP CL4416R S31 C41RP UST-2265-2 S3ESCLS CL4416R1 VC41V C23RV C42T L51K L44LA S42 S31KP L441 CC41R2 SCENARIA View ECHELON Synergy OASIS CTL Coil, OASIS OD Flexible Body Coil (L AND XL), OASIS Rapid Foot Coil

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-04-24
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 2026-04-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-04-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-05-31
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-01-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-09-25
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-09-25
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-09-25
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 2024-04-29
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2021-04-22
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
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-05-31
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-05-31
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-05-31
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2021-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-05-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-07-01
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-09-19
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-05-31
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-12-14
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-04-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2021-04-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-07-14
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
3018423337 FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa KASHIWA-SHI Chiba, JP
3019784575 FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji KOKUBUNJI-SHI Tokyo, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25
K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07
K142628 Siemens Medi Cal Solutions, Inc. Acuson SC2000 Diagnostic Ultrasound System 2014-10-10
K132171 Supersonic Imagine AIXPLORER 2013-09-24
K222441 Bk Medical Aps Ultrasound System 2300 2022-12-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024 FUJIFILM Healthcare Americas Corporation 2
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032109225. Last updated year: 2026. Please use registration number 3032109225 when referencing this establishment in official correspondence.
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