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

    MODIFICATION TO: NUCAMMA RX

    K Number: K032779 · Decision Dec 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    7
    Review Days
    100

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    Basic Information

    Device Name
    MODIFICATION TO: NUCAMMA RX
    K Number
    K032779
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Is2 Research, Inc.
    Date Received
    September 8, 2003
    Decision Date
    December 17, 2003
    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
    K040057 MOBILE COMPACT DIGITAL CARDIAC CAMERA
    K033956 MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)
    K013667 BCC GAMMA CAMERA
    K003882 NUCAMMA BI90
    K982044 NUCAMMA R+
    K982045 NUCAMMA RX