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510(k) Data Aggregation

    K Number
    K013875
    Device Name
    MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    2002-09-27

    (308 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Software translates the ASCII output from a treatment plan to G code for use on a milling machine.

    Works with various treatment plan outputs and translates the treatment plan into G code that can be used on a milling machine to produce a compensating shield.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the MED-TEC Compensator Block Cutter Software, which indicates the device is substantially equivalent to legally marketed predicate devices. However, it does not include details on acceptance criteria, specific device performance, study methodology, sample sizes, ground truth establishment, or expert qualifications. The attachment only provides the "Indications For Use" for the software.

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