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510(k) Data Aggregation

    K Number
    K052537
    Device Name
    CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0
    Manufacturer
    AMERICAN MEDICAL SALES, INC.
    Date Cleared
    2005-11-16

    (62 days)

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

    AMERICAN MEDICAL SALES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Catella Diagnostic Workstation, Version 4.0, is a medical image and information management system that allows easy viewing, selection, processing, printing, telecommunications, and media interchange of multimodality medical images from a variety of diagnostic imaging systems. The Catella PACS interfaces to various storage and printing devices using DICOM or similar interface standards. The system is available for diagnostic and nondiagnostic workstations, including workstations designed as web-based, remote viewers or CD-viewer workstations. The software may be installed as a PC-based stand alone system, a software application, a web-based or SDK format, and is designed to be integrated with various DICOM compliant OEM systems. The Catella PACS displays, stores, prints, and telecommunicates images from a number of medical modalities, including but not limited to MR, CT, DR, CR, X-ray, Angiography, Ultrasound, or digitizers. The Catella Diagnostic Workstation, Version 4.0 performs other user-defined post-processing functions, such as multi-planar reformatting of images. The Catella PACS can display processed data from certain FDA-cleared third party image processing systems that create DICOM output. With proper links, the Catella Workstation also can invoke FDA-cleared third party image processing systems for advanced image processing, such as 3D display. It can also access RIS and HIS systems and can be used to review patient information. The Catella Diagnostic Workstation, Version 4.0, is not intended for use for primary diagnostic interpretation of mammographic images.
    Device Description
    The Catella Diagnostic Workstation, Version 4.0 is a multi-modality PCdriven review workstation that operates on a standard Windows operating system. Each workstation may include a high performance computer, communications capability, medical grade, high-resolution monitors and video cards, trackball or mouse, microphone, keyboard, foot pedal and ergonomically designed display cart. The system is available for diagnostic and non-diagnostic workstations, including workstations designed as webbased, remote viewers or CD-viewer workstations. The software may be installed as a PC-based stand alone system, a software application, a webbased or SDK format, and is designed to be integrated with various DICOM compliant OEM systems. The Catella Diagnostic Workstation, Version 4.0 includes the following software features: - The Catella Diagnostic Workstation, Version 4.0 allows the user to . select a study to view, archive, and perform administrative tasks. - . The Catella Diagnostic Workstation, Version 4.0 includes multimodality viewing capabilities, allowing the user to view images from various modalities. - . Digitized mammographic images displayed on the Catella Diagnostic Workstation, Verison 4.0 must not be used for primary diagnostic interpretation. - . Lossy compressed mammographic images should not be used for primary diagnosis and contain a warning. - DICOM query/retrieve and print, which allows retrieval of DICOM . data from any DICOM-compliant device that is configured for query and retrieval. The Catella Diagnostic Workstation, Version 4.0 also provides various software components described in the User Manual, including: - . Software for viewing images, playing audio, or viewing or dictating reports - . Zoom, pan, window/level - . Menu options - Annotations, standard software tools . - . Stack/Cine viewing mode - . DICOM query/receive - DICOM-compliant methods of lossless and lossy image compression . (JPEG2000 and JPEG) - . Outputs DICOM medical image data to printers that adhere to appropriate regulatory standards. - . Outputs medical imaging data in DICOM format to archives that use appropriate media that are designed to prevent data loss. - . Enables storage and reading of digitized images.
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