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510(k) Data Aggregation

    K Number
    K242545
    Device Name
    RadiForce MX317W-PA
    Manufacturer
    EIZO Corporation
    Date Cleared
    2025-05-23

    (269 days)

    Product Code
    PZZ
    Regulation Number
    864.3700
    Why did this record match?
    Product Code :

    PZZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RadiForce MX317W-PA is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. RadiForce MX317W-PA is an aid to the pathologist and is used for review and interpretation of histopathology slides for the purposes of primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using this product. The display is not intended for use with digital images from frozen section, cytology, or non- formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
    Device Description
    RadiForce MX317W-PA is a color LCD monitor for viewing digital images of histopathology slides. The color LCD panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size is 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1674 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve, a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced. "Patho" is for intended digital pathology use mode.
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    K Number
    K233119
    Device Name
    8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
    Manufacturer
    Shenzhen Beacon Display Technology Co., Ltd.
    Date Cleared
    2024-12-28

    (458 days)

    Product Code
    PZZ
    Regulation Number
    864.3700
    Why did this record match?
    Product Code :

    PZZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    8MP Color LCD Displays C811W, C811WT, PA27 and PA27T are intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. They are an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T. The displays are not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
    Device Description
    The C811WT. PA27T. C811W. PA27 are 8MP Color LCD Displays, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners that have been validated for use with the display. The displays are equipped with a 27-inch color LCD panel with a fine pixel pitch. They use the latest generation of LED backlight panels. The built-in brightness stabilization control circuits make sure the brightness of these displays is stable in their life, so the products meet the demands of high precision medical imaging. For C811WT. PA27T. C811W. PA27. the only difference is the capacitive touch screen. C811WT, PA27T have the same capacitive touch screen. C811W, PA27 don't have a capacitive touch screen. The difference between C811WT and PA27T is only different customers which results in the two models. The difference between C811W and PA27 is only different customers which results in the two models.
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    K Number
    K172922
    Device Name
    MMPC-4127F1
    Manufacturer
    Barco N.V.
    Date Cleared
    2017-12-21

    (87 days)

    Product Code
    PZZ
    Regulation Number
    864.3700
    Why did this record match?
    Product Code :

    PZZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners that have been validated for use with this device, for review and interpretation by pathologists. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
    Device Description
    The MMPC-4127F1, also marketed as the PP27QHD, is a stabilized, color-calibrated display system designed to review and interpret digital images of surgical pathology slides. The display is equipped with a 27-inch color LCD panel with a fine pixel pitch that can be calibrated to the sRGB gamut. Accessories: - QAWeb quality assurance software - DisplayPort cable - USB cable - AC power cord cables
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