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Data / Medical devices / Japan / FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji

FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji: FDA-registered device maker in KOKUBUNJI-SHI Tokyo, Japan, 24 510(k) clearances

FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji is registered with the FDA (registration 3019784575) in KOKUBUNJI-SHI Tokyo, Japan. It lists 3 device types. The FDA files 24 510(k) clearances under its listings, the newest dated August 12, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji
FDA registration number
3019784575
Address
3-1-1 Higashikoigakubo, KOKUBUNJI-SHI Tokyo, Japan, 185-0014
Owner or operator
FUJIFILM Corporation (10081521)
Roles
Manufacturer, Specification developer
First device listed
April 24, 2021
Registered through
2026
Brand names listed
ALOKA SSD-Alpha 7, ARIETTA 50, ARIETTA 60 / ARIETTA S60 / ARIETTA V60, ARIETTA 65, ARIETTA 650, ARIETTA 70, ARIETTA 750, ARIETTA 850 and more

Devices it lists

DeviceProduct codeClassRoleSource
System, Imaging, Pulsed Doppler, UltrasonicIYN2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufacturer, Specification developeraccessdata.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
August 12, 2026K261170BA-004CCITXSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
November 20, 2023K231941ARIETTA x10IYNSubstantially EquivalentFUJIFILM Healthcare Americas Corporationaccessdata.fda.gov
April 29, 2022K220295ARIETTA 50IYNSubstantially EquivalentFujifilm Healthcare Corporationaccessdata.fda.gov
November 4, 2020K202422Arietta 65IYNSubstantially 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
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
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
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
August 30, 2007K072285ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEMITXSubstantially EquivalentAloka Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 12, 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.