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510(k) Data Aggregation

    K Number
    K973315
    Device Name
    THERAPAX DXT 300 MODEL HF-300
    Manufacturer
    PANTAK, INC.
    Date Cleared
    1997-12-02

    (90 days)

    Product Code
    JAD
    Regulation Number
    892.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANTAK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Therapax DXT 300 is a variable high energy X-Ray system intended for superficial to The Therapy radiotherapy treatments of cancerous tumours and lesions. Typical suboutineous include treatment for basal and squamous cell carcinoma, cancerous lung, breast, ribs, rectal adenocarcinoma and other intracavital sites.
    Device Description
    Therapax DXT 300 X-Ray Therapy Device - Model HF-300
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    K Number
    K971074
    Device Name
    THERAPAX SXT 150
    Manufacturer
    PANTAK, INC.
    Date Cleared
    1997-06-13

    (81 days)

    Product Code
    JAD
    Regulation Number
    892.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANTAK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Therapax SXT 150 is a variable low energy x-ray system intended for superficial cases and lesions. Typical applications include radiotherapy treatments of cancerous tumors and research. Typical treatments include treatment for basal cell carcinoma, squamous cell carcinoma, Karpos's Sarcoma, rectal adenocarcinoma and other intracavital sites.
    Device Description
    variable low energy x-ray system
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