BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE

    K Number: K080784 · Decision Apr 2, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    6
    Review Days
    13

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    Basic Information

    Device Name
    WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE
    K Number
    K080784
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ultraspect , Ltd.
    Date Received
    March 20, 2008
    Decision Date
    April 2, 2008
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

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    Other Clearances by Ultraspect , Ltd.

    K Number Device Name
    K103710 WBR XPRESS PET
    K091073 WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS
    K081201 WBR XPRESS3.CARDIAC
    K050815 XACT.CARDIAC & XPRESS.CARDIAC
    K040370 WBR-FHR, WBR-FWB