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510(k) Data Aggregation

    K Number
    K073714
    Device Name
    TRAUMACAD VERSION 2.0
    Manufacturer
    ORTHOCRAT, LTD.
    Date Cleared
    2008-03-19

    (79 days)

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

    ORTHOCRAT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TraumaCAD program is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.
    Device Description
    TraumaCad allows surgeons to evaluate and manipulate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute complex measurements in a click, and facilitate the film-less orthopedic practice. The program features full PACS integration and an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad supports DICOM and enables the importing and exporting any PACS file (X-ray, CT or MR) from a central PACS system, a CD or from a local workstation. JPG, scanner or digital camera images can also be imported. TraumaCad software is installed and runs locally on a computer (PC) and interacts with a PACS system. Both a standalone and a client/server version of TraumaCad are available.
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    K Number
    K042816
    Device Name
    TRAUMACAD 1.2
    Manufacturer
    ORTHOCRAT, LTD.
    Date Cleared
    2004-11-10

    (29 days)

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

    ORTHOCRAT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TraumaCAD program is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.
    Device Description
    TraumaCAD is a software application to be used by licensed physicians for preoperative planning of orthopedic surgical procedures. The application can be used in a workstation or in a PC as standalone software. The system allows the physician to import medical images, and to overlay them with templates of medical prosthesis and to perform measurements to facilitate surgical planning. The surgical plan is available on the hospital network, and can be sent to the Operating Room prior to surgery. The TarumaCAD does not have any image acquisition or image storage functionality, this is the responsibility of the systems alongside which TraumaCAD. In addition the system does not specify the requirements for the prosthetic template - this is the responsibility of the prosthetic manufacturer.
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