Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K170729
    Device Name
    Examion X-AQS
    Manufacturer
    Date Cleared
    2017-07-18

    (131 days)

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

    Examion GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Examion X-AQS™ software, used together with a digital X-ray detector is a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, optimizing window level and width of acquired images, rotating images, measuring images and other features used for imaging processing. The Examion X-AQS™ system is compatible with the DICOM 3.x communications standard. It can transfer images processed in PACS and print images with a film printer compatible with DICOM 3.x by using DICOM and network systems. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians. Contraindications: Examion X-AQS™ is not intended for creation of fluoroscopic/ radioscopic. or angiographic images. The main functions of the Examion X-AQS™ system are: a) Acquisition and storage of digital X-ray images from a digital X-ray Detector, b) Input Study information (natient information, exam information), c) Management of stored (archived) images, d) Image processing for enhancement of archived images, e) Review of stored images, f) Editing of images, g) DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.), h) For a DR system (X-ray machine and generator and Digital X-ray detector, etc.) or a need to interface with installed X-ray system, the . Ability to configure X-ray exposure condition (kVp, mA, Sec etc.) for various body parts and positions. · Communication between Generator Console and Examion X-AQS™. The X-ray generator control function depends on the X-ray Generator company. The X-ray generator is not part of the Examion X-AQS™ system since the Examion X-AQS™ system can only interface and control the Generator by the algorithm provided by the X-ray Company. The Examion X-AQS™ system can only select or change values of X-ray exposure parameters (kVp. mA second or kVp. mAs) according to the defined value determined by each X-rav company. The Examion X-AQS™ system does not control exposure and electrical charge and calibration X-ray. If the X-ray generator does not allow interfacing with external software the Examion X-AQS™ software cannot be interfaced with X-ray Generator.
    Device Description
    The EXAMION X-AQS system is an enterprise Picture Archiving and Communications System (PACS) used to handle DICOM digital medical images and other associated data. The system enables the receipt of DICOM images from various imaging devices (modalities) like CT, MRT, US DICOM and enables their storage, retrieval, distribution, image manipulation and examination for diagnostic purposes, annotation and report generation The EXAMION X-AQS software system is customizable and scalable to meet various enterprise functional and size requirements. It is a standard based system Integrating the Health Enterprise (IHE) profiles. Digital Imaging and Communications in Medicine (DICOM). Joint Photographic Expert Group (JPEG) and Health Level Seven (HL-7) protocol standards for managing digital medical images as well as patient data. The EXAMION X-AQS supports all types of diagnostic radiographic images, mammography, endoscopy and multi-frame studies. The EXAMION X-AQS console comprise of two major components: - . EXAMION X-AQS PACS Server: A server receives image data in DICOM format from archives, modalities and workstations via universal connections via the hospital network. EXAMION X-AQS PACS Server provides archiving for short term and long term archive. The system provider has to take own appropriate means like redundancy for safety against data loss. - . EXAMION X-AQS PACS Viewer: Client server system that is used to view, edit, manipulate, annotate, and analyze imaqe that are stored on EXAMION X-AQS PACS server. All acquired image data is preserved in the format in which it is received. Changes may be made to the presentation of the image. These changes are saved as a display definition (Presentation states) only and do not alter the acquired image pixel data. All display definitions can be reversed to the original state at any time System interfaces The EXAMION X-AQS software acts in two different ways based on the application. Firstly, as EXAMION X-AQS PACS system involves the interaction between various input devices like RIS work station, diagnostic station (or monitors) or Twain scanner documentation, US grabber, Digitizer CR and DR or any DICOM device and output device. Secondly as a standalone acquisition station which receives images from 3rd party RIS work station and sends to 3rd party PACS systems. The following block diagrams showing the major components of the larger system and interconnections that may be helpful to understand the Examion X-AQS in detail
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1