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

    PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM

    K Number: K945261 · Decision Mar 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    3
    Review Days
    144

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    Basic Information

    Device Name
    PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM
    K Number
    K945261
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ohio Imaging, Inc.
    Date Received
    October 28, 1994
    Decision Date
    March 21, 1995
    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 Ohio Imaging, Inc.

    K Number Device Name
    K934722 PRISM 3000 NUCLEAR GAMMA CAMERA SYSTEM MODIFICATION
    K882312 MODEL 3000 NUCLEAR CAMERA