BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CANON MEDICAL INFORMATICS, INC.

    Reg #: 2134213 · FEI: 3001654007 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    106
    Establishment Types
    3
    Classifications
    9

    Registration Details

    Registration Name
    CANON MEDICAL INFORMATICS, INC.
    Registration Number
    2134213
    FEI Number
    3001654007
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5850 Opus Parkway Suite 300
    City
    MINNETONKA
    State
    MN
    ZIP
    55343
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243240

    Owner / Operator

    Firm Name
    CANON MEDICAL INFORMATICS, INC.
    Operator Number
    9024582
    Address
    5850 OPUS PARKWAY, SUITE 300
    City
    Minnetonka
    State
    MN
    Postal Code
    55343
    Country
    US
    Correspondent
    Vincent J Swenson

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Collimator, Dermatological, Therapeutic X-Ray IYL
    System, Image Processing, Radiological LLZ
    System, Tomography, Computed, Emission KPS
    System, Nuclear Magnetic Resonance Imaging LNH
    Lung Computed Tomography System, Computer-Aided Detection OEB
    Computer, Diagnostic, Programmable DQK
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    Vitrea CT VScore Vitrea Software Package; VSTP-001A Vitrea® CT Dual Energy Image View Olea Medical® Olea MR LC NeuroScape® Olea Medical® Olea MR CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE Vitrea Vitrea Pediatric package Vitrea LT Vitrea Oncology package XA Angio package Vitrea fX Toshiba International XA Angio fX package VitreaAdvanced fX Vitrea Enterprise Suite VitreaWorkstation fX Vitrea Cardiovascular package Vitrea Neurovascular package VitreaAdvanced VitreaWorkStation Medis® Cardiac MR QPlaque® VITREA IMAGE DENOISING SOFTWARE Vitrea, Vitrea fX PerfScape® Medis® Cardiac MR QFlow® MR Workstation TomTecImageArena Visia¿ Dynamic Review Vitrea View CT Cardiac Functional Analysis CT Cardiac Analysis General Vessel Probe CT Multi-Chamber Cardiac Functional Analysis CT VScore CT Colon Analysis VitreaCore ViTALConnect¿ CT Endovascular Stent Planning MR Core TomTec Cardiac Ultrasound Advanced TomTec Cardiac Ultrasound Standard TomTec Radiology Ultrasound Standard TomTec Image Arena and Image Arena Applications VitreaView (Diagnostic) Vitrea Enterprise Viewer 7 TomTec 4D SonoScan TomTec 2D Cardiac Performance Analysis MR Open Rib Multi Modaliy Viewer iCAD® VeraLook CT Colon CAD Workflow Box WBX Mirada RTx Multi Modality Viewer Olea Sphere V3 Medis QFlow Medis Suite Medis QMass Vitrea Software Toshiba Package, VSTP-001A Vitrea Lung Analysis Mirada Oncology Fusion¿ PicomEnterprise Cedars Cardiac Suite MeVis Lung CAD Vitrea CT Colon Analysis VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS CT Brain Perfusion MR Brain Tumor Analysis CT VScore¿ Vitrea CT Brain Perfusion TomTec 4D LV Analysis TomTec 4D MV Assessment Vitrea CT Cardiac Analysis Medis® Cardiac MR QMass® Medis QMass-Advanced Medis QMass-Essential Mirada XD Mirada NMx CT EP Planning CT SUREPlaque VitreaExtend Vitrea 7 Vitrea Advanced Visualization CT Transcatheter Aortic Valve Replacement (TAVR) CT Brain Analysis 4D CT Liver Analysis CT Body Perfusion 4D for fX Vitrea, VitreaWorkStation, Vitrea fX Vitrea Advanced Visualization Version 7.6 Olea Sphere 2.2 Cedars-Sinai Cardiac Suite Cedars-Sinai Medical Center Cardiac Suite-Quantitative Perfusion SPECT (QPS) Cedars-Sinai Medical Center Cardiac Suite-Quantitative Gated SPECT (QGS) Cedars-Sinai Medical Center Cardiac Suite-Quantitative Blood Pool SPECT (QBS) Cedars-Sinai Medical Center Cardiac Suite-Quantitative PET (QPET) CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE TomTec Image Arena 4 and IA Applications 2D Cardiac Performance Analysis TomTec Image-Arena Applications and Research-Arena Applications Merge CADStream CT Lung Analysis Vitrea CT Lung Density Analysis CT Fat Assessment Vitrea CT Myocardial Perfusion Corridor4DM CT VScore+

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Device in the United States for Export Only