Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K031567
    Device Name
    3D INVIVO BY CSIST
    Date Cleared
    2003-10-02

    (136 days)

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

    CHUNG-SHAN INSTITUTE OF SCIENCE AND TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    3D inVIVO™ is a PACS System used to acquire, transmit, view, and store image or patient data. This data can be transmitted, stored, and viewed over a computer network or off-site using an Internet connection. The typical users of this system are trained professionals including radiologist, physicians, technicians, and nurses. The 3D inVIVO™ is indicated for capture and storage of 2D images from ultrasound systems and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume and are not intended for use in diagnosis or quantitative measurements.
    Device Description
    The CSIST 3D inVIVO™ interactive 3D diagnostic ultrasound system (3DUS) acquires a set of successive 2D ultrasound images from Ultrasound system and coverts them into a 3D ultrasound image, stores the 3DUS images in the Image Archive of DICOM Image Server, views patient data and medical images via the Intranet or Internet, supplies image availability information to the Department System Scheduler/Order Filler with DICOM 3.x standard, and accept schedule information and updated procedure information from the Department System Scheduler/Order Filler with HL7 version 2.4 standard. CSIST Interactive 3DUS system is a PC-based Modality with operating system of MS Windows NT/2000/XP. 3D inVIVO™ provides the advanced process functions, such as : - Supports the freehand scanning, 3D image acquisition, and 3D reconstruction. - Acquires images from ultrasound system in real time. - Supports the ultrasound image storage and ultrasound multi-frame image storage. - Converts non-DICOM to DICOM format. - Supports the GUI functions: zoom, pan, pseudo-color setting, threshold setting, Gamma correction, and thumbnail. - Provides the DICOM query and retrieve services (images and presentation states). - Displays the cut planes of 3D image along the long axis or the short axis. - Provides 3D rendering modes: MIP, X-ray, translucent, surface, slicing, and 3D cine. - Supports distance/area/angle measurements. - Supports Tele-medicine (audio, video, and text) between regional medicine center and remote clients.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1