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510(k) Data Aggregation

    K Number
    K033825
    Device Name
    ORTHOPACS
    Manufacturer
    ETRAUMA.COM CORP.
    Date Cleared
    2004-02-02

    (54 days)

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

    ETRAUMA.COM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OrthoPACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
    Device Description
    eTrauma's OrthoPACS is a Digital Info-Imaging System for orthopaedic specific applications in office, private practice, surgery and clinics. The system allows orthopaedic surgcons to navigate quickly through a typical office day by using an efficient and fast system for viewing clinical images and retrieval of information regarding patient historicals whether tocal or residing on other digital information systems such as electronic medical record and/or practice management software. The four general classes of users for OrthoPACS include x-ray technicians, office managers, physicians and nurses. OrthoPACS consists of the following components: Acquisition and Transmission Modules, Viewing Station Module, Storage Module, RemoteImage Accessibility.
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    K Number
    K994228
    Device Name
    REMOTEIMAGE SYSTEM
    Manufacturer
    ETRAUMA.COM CORP.
    Date Cleared
    2000-02-22

    (69 days)

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

    ETRAUMA.COM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Remotelmage™ System is indicated to be used for remote viewing of medical image data.
    Device Description
    Remotelmage is a client-server software system designed to allow access to medical images by licensed medical professionals. This product is intended to allow the review of images from a modality of digital imaging systems (including the Vidar (k933632) film digitizer, a digital camera, a radiography system (PACS) or other modality) using a personal computer for standard Internet access. Remotelmage software is installed on a computer configured with connections to a mode of digital imaging and the internet. Once images are obtained, the Remotelmage™ software converts the images from their original format to JPEG format and transmits them over 128 bit SSL encryption to an Internet server where they are stored for a specified period of time. Authorized medical personnel, upon password authentication, may download the images over 128 bit SSL encryption for viewing. The software program is written in C and is approximately 1 megabyte in size.
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