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Data / Medical devices / Japan / FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office

FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office: FDA-registered device maker in Kashiwa-shi Chiba, Japan, 47 510(k) clearances

FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office is registered with the FDA (registration 3032109225) in Kashiwa-shi Chiba, Japan. It lists 7 device types. The FDA files 47 510(k) clearances under its listings, the newest dated September 18, 2026. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office
FDA registration number
3032109225
Address
2-1, Shintoyofuta, Kashiwa-shi Chiba, Japan, 277-0804
Owner or operator
FUJIFILM Corporation (10081521)
Roles
Manufacturer
First device listed
April 22, 2021
Registered through
2026
Brand names listed
ALOKA SSD-Alpha 7, APERTO LUCENT MRI System, APERTO Lucent MRI System, ARIETTA 50, ARIETTA 60 / ARIETTA S60 / ARIETTA V60, ARIETTA 65, ARIETTA 650, ARIETTA 70 and more

Devices it lists

DeviceProduct codeClassRoleSource
Coil, Magnetic Resonance, SpecialtyMOS2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Manufactureraccessdata.fda.gov
System, Nuclear Magnetic Resonance ImagingLNH2Manufactureraccessdata.fda.gov
System, Nuclear Magnetic Resonance SpectroscopicLNI2Manufactureraccessdata.fda.gov
System, X-Ray, Tomography, ComputedJAK2Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 18, 2026K261229SCENARIA View Phase 6.0JAKSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
September 16, 2026K261283APERTO Lucent MRI SystemLNHSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
September 4, 2026K253836FCT iStream Phase 2JAKSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
April 6, 2026K253862APERTO Lucent MRI SystemLNHSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
September 17, 2025K251386ECHELON SynergyLNHSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
May 20, 2025K250370SCENARIA View Phase 5.0JAKSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
August 13, 2024K241429ECHELON Synergy MRI SystemLNHSubstantially EquivalentFujifilm Healthcare Corporationaccessdata.fda.gov
May 10, 2024K233629APERTO Lucent MRI SystemLNHSubstantially EquivalentFUJIFILM Healthcare Americas Corporationaccessdata.fda.gov
May 3, 2024K233687ECHELON Synergy V10.0LNHSubstantially EquivalentFUJIFILM Healthcare Americas Corporationaccessdata.fda.gov
April 26, 2024K233583FCT iSTREAM Phase 1JAKSubstantially EquivalentFUJIFILM Healthcare Americas Corporationaccessdata.fda.gov
April 12, 2024K240571OASIS MRI SystemLNHSubstantially EquivalentFujifilm Healthcare Corporationaccessdata.fda.gov
November 20, 2023K231941ARIETTA x10IYNSubstantially EquivalentFUJIFILM Healthcare Americas Corporationaccessdata.fda.gov
July 13, 2023K223426ECHELON Synergy MRI systemLNHSubstantially EquivalentFujifilm Healthcare Corporationaccessdata.fda.gov
January 26, 2023K221619ECHELON Oval V6.2 MRI SystemLNHSubstantially EquivalentFujifilm Healthcare Corporationaccessdata.fda.gov
May 23, 2022K213829SCENARIA ViewJAKSubstantially EquivalentFujifilm Healthcare Corporationaccessdata.fda.gov
April 29, 2022K220295ARIETTA 50IYNSubstantially EquivalentFujifilm Healthcare Corporationaccessdata.fda.gov
October 7, 2021K211406OASIS MRI SystemLNHSubstantially EquivalentHitachi Healthcare Americasaccessdata.fda.gov
November 4, 2020K202422Arietta 65IYNSubstantially EquivalentHitachi Healthcare Americasaccessdata.fda.gov
October 21, 2020K202030OASIS MRI SystemLNHSubstantially EquivalentHitachi Healthcare Americasaccessdata.fda.gov
September 13, 2019K190841SCENARIA ViewJAKSubstantially EquivalentHitachi Healthcare Americasaccessdata.fda.gov
August 9, 2019K191233ARIETTA 750IYNSubstantially EquivalentHitachi Healthcare Americasaccessdata.fda.gov
April 2, 2019K190248ARIETTA 50IYNSubstantially EquivalentHitachi Healthcare Americasaccessdata.fda.gov
January 28, 2019K183456Aloka Arietta 850IYNSubstantially EquivalentHitachi Healthcare Americasaccessdata.fda.gov
July 18, 2018K181376ARIETTA 65IYNSubstantially EquivalentHitachi Healthcare Americas Corporationaccessdata.fda.gov
May 30, 2017K163505ARIETTA PRECISIONIYNSubstantially EquivalentHitachi , Ltd.accessdata.fda.gov
March 3, 2017K163528HITACHI Supria Whole-body X-ray CT System Phase 3JAKSubstantially EquivalentHitachi Medical Systems America, Inc.accessdata.fda.gov
December 15, 2016K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersIYNSubstantially EquivalentHitachi , Ltd.accessdata.fda.gov
November 17, 2016K162583ALOKA LISENDO 880IYNSubstantially EquivalentHitachi , Ltd.accessdata.fda.gov
October 18, 2016K160559NOBLUS™ Ultrasound Diagnostic SystemIYNSubstantially EquivalentHitachi Medical Corporationaccessdata.fda.gov
September 30, 2015K150565Supria Whole-body X-ray CT SystemJAKSubstantially EquivalentHitachi Medical Systems America, Inc.accessdata.fda.gov
October 16, 2014K142618Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound SystemITXSubstantially EquivalentHitachi Aloka Medical America, Inc.accessdata.fda.gov
June 16, 2014K140443ARIETTA 60/ARIETTAS60/ARIETTAV60IYNSubstantially EquivalentHitachi Aloka Medical,Ltd. (Hitachi Aloka Medicalaccessdata.fda.gov
June 11, 2014K140854INTRA-OPERATIVE ULTRASOUND TRANSDUCERITXSubstantially EquivalentHitachi Aloka Medical, Ltd.accessdata.fda.gov
March 28, 2014K134016ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNERIYNSubstantially EquivalentHitachi Aloka Medical,Ltd. (Hitachi Aloka Medicalaccessdata.fda.gov
April 12, 2013K122537PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0IYNSubstantially EquivalentHitachi Aloka Medical,Ltd. (Hitachi Aloka Medicalaccessdata.fda.gov
January 18, 2013K123828PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentHitachi Aloka Medical, Ltd.accessdata.fda.gov
September 26, 2012K122341PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37IYNSubstantially EquivalentHitachi Aloka Medical, Ltd.accessdata.fda.gov
May 1, 2012K113145ECHELON OVAL MRI SYSTEMLNHSubstantially EquivalentHitachi Medical Systems America, Inc.accessdata.fda.gov
September 27, 2011K110673HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNERIYNSubstantially EquivalentHitachi Medical Systems America, Inc.accessdata.fda.gov
November 20, 2009K093488ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEMIYOSubstantially EquivalentAloka Co., Ltd.accessdata.fda.gov
December 19, 2008K083254ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentAloka Co., Ltd.accessdata.fda.gov
February 29, 2008K080176ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentAloka Co., Ltd.accessdata.fda.gov
February 11, 2008K080062OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120MOSSubstantially EquivalentHitachi Medical Systems America, Inc.accessdata.fda.gov
January 18, 2008K073310OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COILMOSSubstantially EquivalentHitachi Medical Corp.accessdata.fda.gov
September 21, 2007K072279MAGNETIC RESONANCE DIAGNOSTIC DEVICELNHSubstantially EquivalentHitachi Medical Systems America, Inc.accessdata.fda.gov
August 30, 2007K072285ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEMITXSubstantially EquivalentAloka Co., Ltd.accessdata.fda.gov
December 12, 2006K063513ECHELON MR-RCC-150 CARDIAC COILMOSSubstantially EquivalentHitachi Medical Systems America, Inc.accessdata.fda.gov

Compare with other makers

Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.