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510(k) Data Aggregation

    K Number
    K192508
    Device Name
    Medsynapse Ris Pacs & Medsynapse VNA
    Date Cleared
    2019-11-22

    (71 days)

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

    Medsynaptic Private Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Medsynapse RIS PACS Software is intended for use as a fully web based application on an off-the shelf PC which is networked with a Medsynapse RIS PACS server. The Medsynapse RIS PACS software can process medical images from DICOM compliant modalities and non DICOM sources. The Medsynapse RIS PACS software provides toolsets for performing measurements on DICOM images, importing and presenting data from modalities (DICOM and non-DICOM), solving clinical calculations, and creating and distributing structured reports. It enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, cardiologists, technologists, sonographers, technicians, nurses and clinicians. MIP, MPR, and Fusion are not intended for Mammography use. Medsynapse VNA is an open standards based archiving methodology used for storing images in non-proprietary format. The Medsynapse RIS PACS Software may be used to process DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography.
    Device Description
    Medsynapse RIS (Radiology Information System) PACS is a fully web based, enterprise-wide application intended for communication, storage, display, printing, and processing of medical images. Its software components perform operations related to image manipulation and measurements relevant to radiology and cardiology. As a software-only device, it does not control image acquisition. Typical users of Medsynapse RIS PACS are radiologists, technologists, sonographers, technicians, nurses, and clinicians. The software runs on standard PC equipment using MS Windows operating systems meeting minimum system requirements. Medsynapse VNA (Vendor Neutral Archive) is an open standards-based archiving methodology used for storing images in non-proprietary format.
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    K Number
    K163158
    Device Name
    MEDSYNAPSE Zero Footprint Viewer
    Date Cleared
    2016-12-02

    (22 days)

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

    MEDSYNAPTIC PRIVATE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    With appropriate display monitors, lighting, image quality, and level of lossy image compression the use of MEDSYNAPSE ZERO FOOTPRINT VIEWER is to distribute medical images & associated documents on desktop (Windows & Linux) & mobile platform (Android, iOS, Blackberry, Windows) using browsers like Internet Explorer, Mozilla Firefox, Safari, UC Browser or Google Chrome within or out of hospital. The users of the systems will be trained healthcare professionals. This software is not appropriate for primary diagnosis of Mammograms.
    Device Description
    MEDSYNAPSE ZERO FOOTPRINT VIEWER allows distribution of images within and outside the Hospital. It acquires, transmits, stores, retrieves, and displays digital images and related patient information from a variety of imaging sources and communicates the information over a network. It facilitates image viewing at diagnostic, reporting, consultation, and remote computer workstations, as well as archiving of pictures on magnetic or optical media using short- or long-term storage devices. MEDSYNAPSE ZERO FOOTPRINT VIEWER allows communication using local or wide-area networks, public communications services, systems that include modality interfaces, and gateways to healthcare facility and departmental information systems.
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