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510(k) Data Aggregation

    K Number
    K160001
    Device Name
    TraumaCad Mobile Release 2.0
    Manufacturer
    Voyant Health Ltd
    Date Cleared
    2016-02-12

    (39 days)

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

    Voyant Health Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TraumaCad Mobile Release 2.0 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 judgment and experience are required to properly use the software is not for primary image interpretation. The software is not for use on mobile phones.
    Device Description
    TraumaCad Mobile Release 2.0 allows surgeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, 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 Mobile Release 2.0 supports DICOM and enables the importing and exporting of image files from a central PACS system, or Quentry (Class I device registered by Brainlab AG in the FDA). TraumaCad Mobile Release 2.0 is the web based version of the predicate device TraumaCad 2.0 (cleared by the FDA on March 19, 2008). The TraumaCad Mobile Release 2.0 has the same basic functionality as the predicate device, but is now available as a web based version on additional platforms. TraumaCad Mobile Release 2.0 is a web based device that can be used on PCs, Mac, or iPad 3, 4 or 5 (Air) and interacts with a PACS system or Quentry. No installation is required. TraumaCad Mobile Release 2.0 provides web based access and should only be used on computers and iPads that are already qualified for wireless use in a clinical setting. TraumaCad Mobile Release 2.0 is not intended for use on mobile phones. Use of TraumaCad Mobile Release 2.0 for planning on a tablet is not to replace planning on a workstation. Use on a tablet is only for situations when a workstation is not available.
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    K Number
    K142923
    Device Name
    TraumaCad Mobile Release 1.0
    Manufacturer
    Voyant Health Ltd
    Date Cleared
    2015-03-05

    (148 days)

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

    Voyant Health Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TraumaCad Mobile Release 1.0 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 judgment and experience are required to properly use the software is not for primary image interpretation. The software is not for use on mobile phones.
    Device Description
    TraumaCad Mobile Release 1.0 allows surqeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitate the film-less orthopedic practice. The program features full PACS integration and an extensive reqularly updated library of digital templates from leading manufacturers. TraumaCad Mobile Release 1.0 supports DICOM and enables the importing and exporting of image files from a central PACS system, or Quentry (Class I device reqistered by Brainlab AG in the FDA). TraumaCad Mobile Release 1.0 is the web based version of the predicate device TraumaCad 2.0 (cleared by the FDA on March 19, 2008). The TraumaCad Mobile Release 1.0 has the same basic functionality and intended use as the predicate device, but is now available as a web based version on additional platforms. The differences between the device and the predicate device do not impact on substantial equivalence. TraumaCad Mobile Release 1.0 is a web based device that can be used on PCs, Mac, or iPad 3, 4 or 5 (Air) and interacts with a PACS system or Quentry. No installation is required. TraumaCad Mobile Release 1.0 provides web based access and should only be used on computers and iPads that are already qualified for wireless use in a clinical setting. TraumaCad Mobile is not intended for use on mobile phones. Use of TraumaCad Mobile for planning on a tablet is not to replace planning on a workstation. Use on a tablet is only for situations when a workstation is not available. In order to access TraumaCad Mobile, the user needs to browse to a specific URL and enter the system via username and password. A Web Application will be available in the iTunes store that will automatically open the browser with the correct URL. The application can be downloaded from iTunes for free but cannot be used without receiving a license to ensure the use by appropriate healthcare professionals. The program features full PACS integration and an extensive reqularly updated library of digital templates from leading manufacturers. TraumaCad Mobile supports DICOM and enables the importing and exporting image files from a central PACS system or from Quentry.
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