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510(k) Data Aggregation

    K Number
    K241499
    Device Name
    21.3” 5MP Color LCD Display UMD5-21B01
    Manufacturer
    ACULA Technology Corp.
    Date Cleared
    2024-06-13

    (16 days)

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

    ACULA Technology Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UMD5-21B01 is indicated for use in displaying radiological images (including full-field digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
    Device Description
    UMD5-21B01 is a 5 mega pixels 21.3" color LCD display for viewing medical images including mammography and digital breast tomosynthesis. The resolution of the display is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm and wide angle LCD technology (IPS) support Dual-link DVI and Displayport signals from workstation or personal computer. Since factory calibrated 3 display modes, each of which is characterized by a specific curve (including DICOM GSDF), a specific luminance range and a pre-defined color temperature, are stored in Lookup Table (LUT) within the display, the tone curve is e.g. DICOM compliant regardless of the display controller used. AcuCal, a general name for the calibration and quality control functions of UMD-series product, includes corresponding firmware (AcuCal-Pro) and management application of PC (AcuCal Manage). AcuCal-Pro is the controlling firmware of this LCD display. AcuCal-Pro can perform the luminance calibration without PC or workstation and also includes the quality control scheme to make sure display quality, especially DICOM conformance. AcuCal Manage is a PC application for managing a group of displays.
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    K Number
    K233336
    Device Name
    21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
    Manufacturer
    ACULA Technology Corp
    Date Cleared
    2024-05-21

    (235 days)

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

    ACULA Technology Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3MP Color LCD Display UMD3-21B01) is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
    Device Description
    UMD3-21B01 (MD3-21B01) is a 3 mega pixels 21.3" color LCD display for viewing medical images, not including mammography. The resolution of the display is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 mm and wide angle LCD technology (IPS) support Dual-link DVI and Displayport signals from workstation or personal computer. Since factory calibrated 3 display modes, each of which is characterized by a specific curve (including DICOM GSDF), a specific luminance range and a pre-defined color temperature, are stored in Lookup Table (LUT) within the display, the tone curve is e.g. DICOM compliant regardless of the display controller used. AcuCal, a general name for the calibration and quality control functions of MD-series product, includes corresponding firmware (AcuCal-Pro) and management application of PC (AcuCal Manage). AcuCal-Pro is the controlling firmware of this LCD display. AcuCal-Pro can perform the luminance calibration without PC or workstation and also includes the quality control scheme to make sure display quality, especially DICOM conformance. AcuCal Mange is a PC application for managing a group of displays.
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