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Data / Medical devices / Japan / Fujifilm Corporation

Fujifilm Corporation: FDA-registered device maker in ASHIGARAKAMI-GUN Kanagawa, Japan, 43 510(k) clearances and 2 PMA approvals

Fujifilm Corporation is registered with the FDA (registration 3001722928) in ASHIGARAKAMI-GUN Kanagawa, Japan. It lists 30 device types. The FDA files 43 510(k) clearances and 2 PMA approvals under its listings, the newest dated August 7, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Fujifilm Corporation
FDA registration number
3001722928
Address
798 Miyanodai Kaisei-Machi, ASHIGARAKAMI-GUN Kanagawa, Japan, 258-8538
Owner or operator
FUJIFILM CORPORATION (8031568)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
October 5, 2006
Registered through
2026
Brand names listed
AMULET Innovality Digital Breast Tomosynthesis Option, ASPIRE Cristalle, ASPIRE Cristalle Digital Breast Tomosynthesis Option, Aspire CRm (CR-IR359), Aspire Cristalle (DVIIm), Aspire Cristalle FDR MS-3500, Biopsy Positioner FDR-2000BPY, DR-ID 1200SDK System and more

Devices it lists

DeviceProduct codeClassRoleSource
Accelerator, Linear, MedicalIYE2Complaint file establishment, Manufactureraccessdata.fda.gov
Automated Radiological Image Processing SoftwareQIH2Complaint file establishment, Manufactureraccessdata.fda.gov
Camera, Multi Format, RadiologicalLMC2Complaint file establishment, Manufactureraccessdata.fda.gov
Colonoscope And Accessories, Flexible/RigidFDF2Specification developeraccessdata.fda.gov
Digital Breast TomosynthesisOTE3Complaint file establishment, Manufactureraccessdata.fda.gov
Endoscope, Accessories, Image Post-Processing For Color EnhancementPEA2Specification developeraccessdata.fda.gov
Endoscope, Accessories, Narrow Band SpectrumNWB2Specification developeraccessdata.fda.gov
Endoscopic Light-Projecting Measuring DeviceQTH2Specification developeraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Specification developeraccessdata.fda.gov
Enteroscope And AccessoriesFDA2Specification developeraccessdata.fda.gov
Film, RadiographicIWZ1Complaint file establishmentaccessdata.fda.gov
Full Field Digital, System, X-Ray, MammographicMUE2Complaint file establishment, Manufactureraccessdata.fda.gov
Gastrointesinal Lesion Software Detection SystemQNP2Specification developeraccessdata.fda.gov
Instrument, Quality-Assurance, RadiologicLHO1Complaint file establishment, Manufactureraccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Specification developeraccessdata.fda.gov
Led Light SourceNTN2Specification developeraccessdata.fda.gov
Lung Computed Tomography System, Computer-Aided DetectionOEB2Complaint file establishmentaccessdata.fda.gov
Screen, Intensifying, RadiographicEAM1Manufactureraccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Complaint file establishment, Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Complaint file establishment, Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Specification developeraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Specification developeraccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Manufactureraccessdata.fda.gov
System, X-Ray, MammographicIZH2Manufactureraccessdata.fda.gov
System, X-Ray, MobileIZL2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
System, X-Ray, StationaryKPR2Complaint file establishment, Manufactureraccessdata.fda.gov
System, X-Ray, TomographicIZF2Complaint file establishment, Manufactureraccessdata.fda.gov
System, X-Ray, Tomography, ComputedJAK2Complaint file establishmentaccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Specification 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 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
May 27, 2026K254075Synapse Lung Nodule AIOEBSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
April 30, 2026K254189Synapse 3D Base Tools (V7.2)QIHSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
March 10, 2026K260595Sonosite iLOOK Ultrasound SystemIYNSubstantially EquivalentFUJIFILM Sonosite, Inc.accessdata.fda.gov
May 21, 2025K243762Synapse 3D Base Tools (V7.0)QIHSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
September 8, 2023K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01FDFSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
November 10, 2022K221677Synapse 3D Base Tools v6.6LLZSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
May 27, 2022K212873Aspire CristalleMUESubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
November 8, 2021K212956FDR Cross (DR-XD 3000)OWBSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
August 27, 2020K200973Synapse 3D Cardiac ToolsLLZSubstantially EquivalentFujifilm Corporatonaccessdata.fda.gov
April 10, 2020K200668DR-ID 1200SDK SystemMQBSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
November 12, 2019K192932FDR D-EVO III flat panel detector systemMQBSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
November 1, 2019K192440FDR SE LiteMQBSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
October 18, 2019K191544Synapse 3D Blood Flow AnalysisLLZSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
July 3, 2019K191495Biopsy PositionerIZHSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
September 25, 2018K181773Synapse 3D Optional ToolsLLZSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
October 27, 2017K173132ASPIRE CristalleMUESubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
June 30, 2017K163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)MQBSubstantially 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
April 6, 2017K162287Synapse 3D Perfusion AnalysisLLZSubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
March 16, 2017K170451FDX Console (DR-ID300CL) SoftwareLLZSubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
March 10, 2017K170084InterLock TrocarGCJSubstantially EquivalentFujifilm New Development 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
December 1, 2014K142521Synapse 3D Liver and Kidney AnalysisLLZSubstantially EquivalentFujifilm Meidcal Systems 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 3, 2014K141514SYNAPSE 3D TENSOR ANALYSISLLZSubstantially EquivalentFujifilm Meidcal Systems U.S.A.,Inc.accessdata.fda.gov
March 25, 2014K133972ASPIRE CRISTALLEMUESubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
June 14, 2013K130542SYNAPSE 3D LUNG AND ABDOMEN ANALYSISLLZSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
January 22, 2013K123566SYNAPSE 3D COLON ANALYSISLLZSubstantially 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
June 1, 2012K120679SYNAPSE 3D NODULE ANALYSISLLZSubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
May 8, 2012K120637SYNAPSE 3D BRAIN PERFUSIONLLZSubstantially 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
May 14, 2008K080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONIZLSubstantially EquivalentShimadzu Corp.accessdata.fda.gov
May 22, 2007K070920FUJI IP CASSETTE TYPE PCIYESubstantially EquivalentFujifilm Medical Systems 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
January 9, 2004K033377FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP LLMCSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
October 28, 1996K962967FUJI MEDICAL DRY IMAGER FM-DP 2636LMCSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
February 26, 1987K862414FUJI CR IMAGING PLATEEAMSubstantially EquivalentParexel Intl. Corp.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
July 10, 2006P050014FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)MUE2August 11, 2009accessdata.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.