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

    NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633

    K Number: K973363 · Decision Jul 2, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    4
    Review Days
    297

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    Basic Information

    Device Name
    NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633
    K Number
    K973363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ml Strategies, Inc.
    Date Received
    September 8, 1997
    Decision Date
    July 2, 1998
    Product Code
    IWI
    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
    IWI Source, Isotope, Sealed, Gold, Titanium, Platinum

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