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510(k) Data Aggregation

    K Number
    K983401
    Device Name
    FRAMEWAVE WEB
    Manufacturer
    ML STRATEGIES, INC.
    Date Cleared
    1998-12-15

    (78 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ML STRATEGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access Radiology "Framewave Web" Image and Information System is indicated for the display and management of radiologic images and associated information stored and transmitted in both compressed and uncompressed form.
    Device Description
    Not Found
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    K Number
    K973363
    Device Name
    NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633
    Manufacturer
    ML STRATEGIES, INC.
    Date Cleared
    1998-07-02

    (297 days)

    Product Code
    IWI
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ML STRATEGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The North American Scientific Corporation's Pd-103 Radionuclide Brachytherapy Source is a device intended to deliver radiation by interstitial, intracavity or surface application for therapy of malignant lesions.
    Device Description
    Pd-103 Radionuclide Brachytherapy Source
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    K Number
    K972271
    Device Name
    NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
    Manufacturer
    ML STRATEGIES, INC.
    Date Cleared
    1997-10-28

    (132 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ML STRATEGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The North American Scientific Corporation's I-125 Radionuclide Brachytherapy Source Model MED3631-A is a device intended to deliver radiation by interstitial intracavity or surface application for therapy of malignant lesions.
    Device Description
    I-125 Radionuclide Brachytherapy Source Model MED3631-A
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