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510(k) Data Aggregation

    K Number
    K173241
    Device Name
    MED-TAB
    Date Cleared
    2018-03-23

    (168 days)

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

    PLUM Medical Solutions GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MED-TAB, is a computer hardware/software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
    Device Description
    MED-TAB is a 13.3" color LCD monitor including a built-in tablet computer for viewing and analyzing of medical images (except those of mammography) from a picture archiving and communication system (PACS). The color panel employs in-plane switching (IPS) technology allowing wide viewing angles. MED-TAB has one regular display mode to visualize non-medical images, and one DICOM factory calibrated display mode to display medical images according to DICOM requlations. The MED-TAB has been calibrated to comply with DICOM Part 14 at the factory. With built-in brightness stabilization circuit. USB adiustment tool and ambient light sensor. stable brightness and persistent calibration can be guaranteed. The MED-TAB can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display damage under heavy operating conditions. The tablet-PC is designed in conformity with IEC60601-1, and IEC60601-1-2 standards. Off-the-shelf (OTS) software is used for the mobile viewer application. It supports DICOM image files as well as other common image formats and PDF files.
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