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510(k) Data Aggregation

    K Number
    K982862
    Device Name
    RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE
    Manufacturer
    APPLICARE MEDICAL IMAGING, B.V.
    Date Cleared
    1998-10-21

    (69 days)

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

    APPLICARE MEDICAL IMAGING, B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RadWorks Medical Imaging Software, from Applicare Medical Imaging, B.V., when installed on an appropriate hardware platform, is intended to provide capability for the acceptance, display, storage, and digital processing of medical images. Options allow for additional capability, including transmission of images over local area networks or public communications channels, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review and revision of studies.
    Device Description
    The RadWorks Quality Control Module is intended to be used by authorized staff to perform various quality control operations on RadWorks imaging studies before they are made available to other locations on the network. These operations include confirming or editing patient characteristics, reviewing the status history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.
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    K Number
    K962699
    Device Name
    RADWORKS MEDICAL IMAGING SOFTWARE
    Manufacturer
    APPLICARE MEDICAL IMAGING, B.V.
    Date Cleared
    1996-08-19

    (39 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLICARE MEDICAL IMAGING, B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RadWorks™ Medical Imaging Software is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices.
    Device Description
    The RadWorks™ medical imaging software consists of a basic module, RadWorks™ Review, and a number of optional modules, to enable the radiologist to view, retrieve, store, import process and transmit medical images. The RadWorks™ software is an open system which runs under the Microsoft® Windows NT™ operating system and it can operate on any hardware platform which meets the minimum hardware requirements and which supports the Windows NTT™ operating system. Windows NT™ based workstations can be made part of UNIX, Novell NetWare, or other networks from major vendors. RadWorks™ is a stand-alone software product and involves no hardware except (optionally) a special graphics card.
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