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510(k) Data Aggregation

    K Number
    K031273
    Device Name
    AMERITEK SURE-POINT HDR NEEDLE TEMPLATE
    Date Cleared
    2003-07-15

    (84 days)

    Product Code
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sure-Point™ HDR Needle Template is designed to allow precision ultrasound probe alignment, placement and position retention of HDR needles in cancer treatments. It was designed to work with commercially available high dose rate remote afterloaders. A specific application is the treatment of prostate (or other) cancer.
    Device Description
    Template for Seeding Device: Probe Stabilization Device. Applicator for Remote Controlled Afterloading Brachytherapy.
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    K Number
    K030518
    Device Name
    AMERITEK SURE-POINT TRACKER SYSTEM
    Date Cleared
    2003-05-20

    (90 days)

    Product Code
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The major intended use of the Amertek Sure-Point Tracker™ is the same as that of its unmodified predecessors cleared in K011581 and K972152: to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer. The Amertek Sure-Point Tracker 100 also allows data from the use of probe location indicators to be fed directly into the brachytherapy planning program, such as that of Varian. Like other basic stabilizers and steppers (e.g. Barzell-Whitmore Omnistand; Tayman Accuquide; Teknar, Proscan), this device is applicable in other surqical procedures or specialties which require accurate instrument fixation, such as cryosurgery, biopsy, and remote afterloading equipment (HDR) such as that used with the Nucletron device.
    Device Description
    Not Found
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    K Number
    K011581
    Device Name
    AMERITEK BRACHYTHERAPY TEMPLATE
    Date Cleared
    2001-07-17

    (55 days)

    Product Code
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Amertek Template is designed to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer.
    Device Description
    Not Found
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