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510(k) Data Aggregation

    K Number
    K152034
    Device Name
    FS-PACS
    Manufacturer
    Date Cleared
    2016-02-23

    (216 days)

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

    EC-WEB CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EC-WEB FS-PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using, DICOM or similar standards. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
    Device Description
    The EC-WEB FS-PACS system is based on DICOM standard application. The main function of FS-PACS is about medical image management within a PACS environment. It's including image archival, retrieval and distribution of medical images. FS-PACS can support the following modality: CR, ES, NM, RF, US, CT, MG, OT, RT, XA, DX, MR, PT, SC, VR, IO, SR. There is no 3D image manipulation functions. FS-PACS provides the following measurement tools: 2-point distance, 3-point angles, ellipse area, and square area. FS-PACS can support the iOS device (i.e., iPad and iPhone). Images reviewed on the mobile device are not intended for diagnostic use. FS-PACS does not include any type of imaging hardware. It does not provide any masking or image filtering functions.
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