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510(k) Data Aggregation

    K Number
    K160620
    Device Name
    Visaris Vision® (Vision C, Vision U. Vision V, Vision X)
    Manufacturer
    VISARIS D.O.O. BELGRADE
    Date Cleared
    2016-03-30

    (26 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISARIS D.O.O. BELGRADE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The purpose of Visaris Vision® is to acquire, store, communicate, display and process medical X-ray images. These radiographic systems are intended for use by a qualified/trained physician or both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use.
    Device Description
    Visaris Vision combines our Visaris Avanse® cleared PACS software (K150725) with all the other components required to make a complete digital diagnostic X-ray system, including tube stands, tube heads, collimators, generators, tables, and (already cleared) digital X-ray panels. Visaris Avanse®, the software component, is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detector technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control, image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module), DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements. These models are available: Vision C: A universal digital system employing an Overhead Tube Crane, a table, and a wall stand. Vision U: A universal U-Arm system Vision V: A floor mounted tube system Vision X: A universal straight Arm system All of these come with the previously cleared Visaris 360, the integrated digital radiology workflow system. (Visaris Avance, K150725)
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    K Number
    K150725
    Device Name
    Visaris Avanse
    Manufacturer
    VISARIS d.o.o. Belgrade
    Date Cleared
    2015-06-08

    (80 days)

    Product Code
    KPR, LLZ
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISARIS d.o.o. Belgrade

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The purpose of Visaris Avanse® is to acquire, store, communicate, display and process medical X-ray images. It offers features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and radiographers. Visaris Avanse supports printing to DICOM compatible printers. Within a network environment Visaris Avanse may provide other modalities with a DICOM worklist and a DICOM worklist service. Images and worklists can be sent and received using the DICOM protocol. Visaris Avanse has a modular system architecture. It consists of the basic application, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. Beside the basic functionality Visaris Avanse also provides a user interface for generator control and image acquisition of medical images DR detectors.
    Device Description
    Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control, image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module). DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements.
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