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510(k) Data Aggregation

    K Number
    K052411
    Device Name
    HIPAX MEDICAL IMAGING SOFTWARE
    Manufacturer
    STEINHART MEDIZINSYSTEME GMBH
    Date Cleared
    2005-09-21

    (23 days)

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

    STEINHART MEDIZINSYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hipax Medical Imaging Software is intended to be used for medical image processing and communication. Medical Images (single images, series or sequences) and corresponding patient data can be received from various sources, e.g. from CR, DR, CT, MRI, US, RF units, secondary capture devices as scanners, video sources, etc. Images can be administrated, displayed, transmitted and stored on the local disk of a workstation as well as on distributed locations across a network, or on optical or digital media, e.g. CD or DVD. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Functions to be carried out using the Hipax Medical Imaging Software are, for example, but not limited to, adjustment of window leveling, defining region of interest, image stacking, MPR, rotation, zoom, measurements. The Hipax Medical Imaging Software can be integrated into a patient administration system.
    Device Description
    The Hipax Medical Imaging Software is an autonomous software with the exception of a dongle for copy protection. It is running under Microsoft Windows 2000/XP operating system. The Hipax Medical Imaging Software has an open system architecture consisting of a basic module and modules for the research and the image acquisition, storage and communication to be added as an option. The functions of the Hipax Medical Imaging Software correspond to the features described for the Predicate Devices. Displaying any medical image, for example, from CT, MRI, CR, US, endoscopy, gastroscopy, and other medical specialists (e.g. window leveling, ROIs, edge enhancement, scaling, cine-loop, measurement, writing and marking, Child-Pugh score, histogram etc.). Multiplanar Reconstruction is available as an option. Like the Predicate Devices, the Radworks Medical Imaging Software or the eFilm Workstation, the Hipax Medical Imaging Software offers modules for image acquisition from video sources (Video Module), digitizers (X-ray Digitizing Module), or CR systems (CR-Connection Module). Within a network DICOM worklists can be received and images can be sent and received using the DICOM protocol. Image exchange between two remote Hipax workstations or other Hipax programs via phone lines, broadband, satellite, etc. can be carried out using the Hipax DICOM Communication Software. The DICOM Email module, which is also part of the Radworks Modules, is available to transmit images as Emails. Images can be compressed and encrypted. The DICOM Print Module supports DICOM 3.0 primary. Using the Patient CD Module, images can be written on CD to be handed out to patients on digital media, e.g. DVD. To burn CDs or DVDs automatically, a CD/DVD robot can be connected.
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