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

    PENN-PET SCANNER

    K Number: K930428 · Decision Jun 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    4
    Review Days
    133

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    Basic Information

    Device Name
    PENN-PET SCANNER
    K Number
    K930428
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ugm Medical Systems, Inc.
    Date Received
    January 26, 1993
    Decision Date
    June 8, 1993
    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 Ugm Medical Systems, Inc.

    K Number Device Name
    K973396 QUEST PET IMAGING SYSTEM
    K945721 PENN-PET SCANNER
    K890100 PENN-PET SCANNER