BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MOBILE COMPACT DIGITAL CARDIAC CAMERA

    K Number: K040057 · Decision Feb 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    7
    Review Days
    20

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    Basic Information

    Device Name
    MOBILE COMPACT DIGITAL CARDIAC CAMERA
    K Number
    K040057
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Is2 Research, Inc.
    Date Received
    January 13, 2004
    Decision Date
    February 2, 2004
    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 Is2 Research, Inc.

    K Number Device Name
    K033956 MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)
    K032779 MODIFICATION TO: NUCAMMA RX
    K013667 BCC GAMMA CAMERA
    K003882 NUCAMMA BI90
    K982044 NUCAMMA R+
    K982045 NUCAMMA RX