BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VIATRONIX V3D COLON, REVISION 1.3

    K Number: K040126 · Decision Apr 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    VIATRONIX V3D COLON, REVISION 1.3
    K Number
    K040126
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Viatronix, Inc.
    Date Received
    January 20, 2004
    Decision Date
    April 19, 2004
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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    Other Clearances by Viatronix, Inc.

    K Number Device Name
    K083293 VIATRONIX V3D-CARDIAC, REVISION 1.0
    K033361 VIATRONIX V3D VASCULAR, REVISION 1.0
    K032483 VIATRONIX V3D EXPLORER, REVISION 1.2
    K022789 VIATRONIX V3D EXPLORER
    K020658 VIATRONIX V3D COLON
    K013146 VIATRONIC V3D CALCIUM SCORING
    K002780 VIATRONIX VISUALIZATION SYSTEM (VVS)