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

FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office: FDA-registered device maker in HANAMAKI-SHI Iwate, Japan, 30 510(k) clearances and 1 PMA approval

FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office is registered with the FDA (registration 3003775006) in HANAMAKI-SHI Iwate, Japan. It lists 26 device types. The FDA files 30 510(k) clearances and 1 PMA approval under its listings, the newest dated August 7, 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 Hanamaki Office
FDA registration number
3003775006
Address
2-1-3 Kitayuguchi, HANAMAKI-SHI Iwate, Japan, 025-0301
Owner or operator
FUJIFILM CORPORATION (8031568)
Roles
Exporter to the US, Manufacturer
First device listed
October 25, 2006
Registered through
2026
Brand names listed
AMULET Innovality Digital Breast Tomosynthesis Option, ASPIRE Cristalle, ASPIRE Cristalle Digital Breast Tomosynthesis Option, AW-500 A-W BUTTON FOR G-5 SCOPES, AW-601 Air/Water Button for Ultrasonic Endoscope, AW-602 Air/Water Valve, AW-603 Air/Water Valve, Aspire CRm (CR-IR359) and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Photographic, For Endoscope (Exclude Light Sources)FEM1Manufactureraccessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For EndoscopeFFY1Manufactureraccessdata.fda.gov
Automated Radiological Image Processing SoftwareQIH2Manufactureraccessdata.fda.gov
Bulb, Inflation, For EndoscopeFCY1Manufactureraccessdata.fda.gov
Colonoscope And Accessories, Flexible/RigidFDF2Manufactureraccessdata.fda.gov
Digital Breast TomosynthesisOTE3Manufactureraccessdata.fda.gov
Endoscope, Accessories, Image Post-Processing For Color EnhancementPEA2Manufactureraccessdata.fda.gov
Endoscope, Accessories, Narrow Band SpectrumNWB2Manufactureraccessdata.fda.gov
Endoscopic Light-Projecting Measuring DeviceQTH2Manufactureraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Manufactureraccessdata.fda.gov
Enteroscope And AccessoriesFDA2Manufactureraccessdata.fda.gov
Full Field Digital, System, X-Ray, MammographicMUE2Manufactureraccessdata.fda.gov
Gastrointesinal Lesion Software Detection SystemQNP2Manufactureraccessdata.fda.gov
Gastroscope And Accessories, Flexible/RigidFDS2Manufactureraccessdata.fda.gov
Instrument, Quality-Assurance, RadiologicLHO1Manufactureraccessdata.fda.gov
Insufflator, Automatic Carbon-Dioxide For EndoscopeFCX2Manufactureraccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
Led Light SourceNTN2Manufactureraccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Exporter to the US, Manufactureraccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Manufactureraccessdata.fda.gov
System, X-Ray, MammographicIZH2Manufactureraccessdata.fda.gov
System, X-Ray, MobileIZL2Manufactureraccessdata.fda.gov
System, X-Ray, StationaryKPR2Manufactureraccessdata.fda.gov
System, X-Ray, TomographicIZF2Manufactureraccessdata.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 7, 2026K260567EW10-EC02 Endoscopy Support ProgramQNPSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
July 2, 2026K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FETSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
April 30, 2026K254189Synapse 3D Base Tools (V7.2)QIHSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
May 21, 2025K243762Synapse 3D Base Tools (V7.0)QIHSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
December 15, 2023K230751EW10-EC02 Endoscopy Support ProgramQNPSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
November 10, 2022K221677Synapse 3D Base Tools v6.6LLZSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
May 27, 2022K212873Aspire CristalleMUESubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
December 2, 2021K212950FUJIFILM Video Laparoscope EL-R740M30GCJSubstantially EquivalentFujifilm Corporatonaccessdata.fda.gov
November 8, 2021K212956FDR Cross (DR-XD 3000)OWBSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
August 20, 2020K202130FUJIFILM Video LaparoscopeGCJSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
April 10, 2020K200668DR-ID 1200SDK SystemMQBSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
February 20, 2020K192918Video Laparoscope, Video Processor, Light SourceGCJSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
November 12, 2019K192932FDR D-EVO III flat panel detector systemMQBSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
July 3, 2019K191495Biopsy PositionerIZHSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
May 25, 2018K180711FUJIFILM Endoscopic CO2 Regulator GW-100FCXSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
March 1, 2018K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603FDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
October 27, 2017K173132ASPIRE CristalleMUESubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
April 24, 2017K170858FDR AQRO (DR-XD 1000)IZLSubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
December 15, 2015K153483Balloon controller PB-30FDFSubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
November 5, 2015K152138FDR D-EVO GL Flat Panel Detector SystemMQBSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
October 21, 2014K142003FDR D-EVO II FLAT PANEL DETECTOR SYSTEMMQBSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
September 9, 2014K133976FUJIFILM ENDOSCOPIC CO2 REGULATORFCXSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
March 25, 2014K133972ASPIRE CRISTALLEMUESubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
January 10, 2014K132210FUJIFILM 600 SERIES ENDOSCOPESFDFSubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
November 20, 2012K122454FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTIONKPRSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
November 20, 2012K121499FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEMIZFSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
December 8, 2011K111646ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCRMUESubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
September 30, 2011K111865WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATUREMQBSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
August 30, 2011K111548WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SEMQBSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
August 25, 2004K042023FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READERMQBSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
January 10, 2017P160031ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTIONOTE4February 13, 2023accessdata.fda.gov

Compare with other makers

Updated August 7, 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.