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The device is intended to display medical images from endoscopic camera systems and other compatible medical image systems. The device is a medical grade monitor for real-time use during endoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, doctor's offices, clinics and similar medical environments.

The MDEC-2523 is a medical grade monitor with a 23,8 inch color TFT-LDC screen size and is intended to display medical images from endoscopic or laparoscopic camera systems and other compatible medical image systems. The MDEC-2523 consists of an LCD panel and LED backlight integrated into a plastic housing body with an internal metal chassis structure, that also integrates the electronics, sensors, and interconnections. The MDEC-2523 encloses user controls that are used to control and configure the device via the embedded on screen display (OSD) software. The device has a glass cover to protect the LCD panel and allow easy cleaning. The MDEC-2523 is powered by means of an internal power supply. This monitor displays color video images that are output from medical imaging systems on the LCD (liquid crystal display) panel.

The display is intended to be used in displaying and viewing digital images, including standard and multiframe digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is especially designed for breast tomosynthesis (3D mammography) applications, breast MRI and breast US. It is especially designed for CT and ultrasound including vascular and gynaecological US.

The Coronis OneLook® (MDMC-32133) is a medical computer display designed for general radiology, mammography and tomosynthesis applications. The device can also be used for home reading in radiology. The display is a high-resolution LCD monitor with improved technical chat are important for accurate medical image review: high luminance, good luminance ratio and luminance ratio and luminance stability. The medical display comes with special image-enhancing technologies to ensure consistent brightne of the display, noise-free images (=good luminance uniformity), ergonomic reading and automated compliance with DICOM and other medical image quality standards and guidelines. These technologies help the radiologist to make a swift and accurate diagnosis. The displays can be used optionally with the downloadable QAWeb Enterprise software, listed under D332294 as a class 1 device with product code LHO. QAWeb Enterprise is a calibration software that is intended as a quality assurance software for the displays. QAWeb Enterprise software helps to keep the display DICOM compliant. The display can be used optionally with the downloadable Intuitive Workflow Tools, cleared in K191845 as a class 2 device with product code PGY. The Intuitive Workflow Tools are accessories for image enhancement on diagnostic displays: - SpotView: The Barco SpotView display feature allows focusing on a region of interest in an image by boosting the display's backlight such that the maximum luminance in provided inside the region of interest. SpotView also enables focused observation during reading by dimming images outside the region of increasing the contrast in this region. Also magnification and inversion of pixels are possible with SpotView. -AAM – Application Appearance Manager: This workflow tool allows you to set the luminance as well as the color space for each application that is on the workstation. There are often multiple windows open on a screen, but not all of them need the hightness These applications are addressed by the general term 'Intuitive Workflow Tools'. The integration of the Intuitive Workflow Tools with the displays have been de-risked, verified and validated to ensure that they do not affect the safety and effectiveness of the displays. The display can be used with or without the Barco MXRT display controller boards. The display controller board is installed in a PACS workstation computer, connected to the display can optionally be used with a touchpad, which is a controlling device (e.g. like a mouse or trackball) that makes it easier to work with diagnostic images and to use the IWTs.

The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The display may be used in dental applications.

Both the Nio Color 2MP (MDNC-2521) and the Nio Color 3MP (MDNC-3521) are medical computer displays designed for general radiology imaging applications. The MDNC-3521 model can also be used in dental applications. The devices can also be used for home reading in radiology. The MDNC-2521 is a derivative of the MDNC-2221. The MDNC-3521 is a derivative of the MDNC-3421. The modified displays are effectively identical to the respective predicate devices except for the following changes: Updated LCD panel with same resolution and dimensions compared to the respective predicate devices New housing, display stand and internal mechanics, with similar functionality and design principle compared to the respective predicate devices Updated internal electronics boards, with similar functionality and design principle compared to the respective predicate devices Updated firmware, with similar functionality and design principle compared to the respective predicate devices New packaging, with similar functionality and design principle compared to the respective predicate devices or any other Barco diagnostic display Rephrasing of the intended usage environment, because of the evolution towards more home reading in radiology Small update in the intended user description The modified device has the following similarities compared to the unmodified device: The same intended use The same operating principle The same fundamental technology The displays can be used optionally with QAWeb Enterprise software, listed under D332294 as a class 1 device with product code LHO. QAWeb Enterprise is a calibration software that is intended as a quality assurance software for the displays. QAWeb Enterprise software helps to keep the display DICOM compliant. The display can be used optionally with Intuitive Workflow Tools, cleared in K191845 as a class 2 device with product code PGY. The Intuitive Workflow Tools are accessories for image enhancement on diagnostic displays: SpotView: The Barco SpotView display feature allows focusing on a region of interest in an image by boosting the display's backlight such that the maximum luminance in provided inside the region of interest. SpotView also enables focused observation during reading by dimming images outside the region of interest and increasing the contrast in this region. Also magnification and inversion of pixels are possible with SpotView. AAM - Application Appearance Manager: This workflow tool allows you to set the luminance as well as the color space for each application that is on the workstation. There are often multiple windows open on a screen, but not all of them need the high brightness of the diagnostic applications.

The Barco Digital Dermatoscope is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners.

The Barco Demetra BDEM-01 is designed to capture images of the skin and optimize the imaging and documentation workflow. The “Barco Demetra BDEM-01” consists of a hardware device and a software application. The hardware device is a portable, battery powered medical device for acquiring and visualizing images of the skin. The device acquires multispectral optical dermoscopic images in a contact mode (device in contact with the skin). In addition, the device can also acquire a clinical close-up image, when it is held at up to 10 to 15 cm from the skin, and a clinical overview image when it is held at a distance of approximately 35-55 cm from the skin. The stand-alone software application is cloud software with a related web application. The cloud software can generate reports containing white light dermoscopic images and clinical photographs of the skin to be reviewed by trained medical practitioners.

The Barco MDPC-8127 device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed digital pathology image viewing software that have been validated for use with this device. It is 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 the MDPC-8127. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

The Barco MDPC-8127 is a medical, color-calibrated display, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners and digital pathology image viewing software that have been validated for use with the display. The use of the MDPC-8127 display with scanners and viewing software is determined by using verified test methods to establish the display's capability to meet or exceed the performance specifications and the intended color space specified by the IVD-labeled whole-slide imaging scanners and digital pathology image viewing software. The display uses built-in techniques and technology to ensure constant accuracy over time. The MDPC-8127 consists of an 8 mega-pixel, 27-inch color LCD-panel with internal electronics platform. It is calibrated to defined color spaces for whole-slide imaging and is compatible with digital pathology viewinq software that utilizes defined color spaces to ensure images are displayed in intended colors.

The Barco Demetra Analytics Toolkit is a non-invasive skin analysis system. The Barco Demetra Skin Parameter Maps Tool provides maps that show the relative location of blood and pigment. The Barco Demetra Skin Parameter Maps Tool is intended only to complement dermoscopy.

The Barco Demetra Analytics Toolkit is a software application used to support analysis of dermoscopic images captured with the Barco Demetra BDEM-01 dermatoscope (K192829). The system is intended for use by medical practitioners. Scatter Contrast Maps provide additional information to dermoscopy by highlighting surface contours. The Skin Parameter Maps Tool provides images generated from multispectral image sets and aids the user in visualizing blood and pigment patterns in the skin. The output of the Skin Parameter Maps is shown to the user as grayscale two-dimensional maps. The maps are intended only to complement dermoscopy.

The display is intended to be used in displaying digital images, including standard and multiframe digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

The MDNC-12130 (Nio Fusion 12MP) is a medical computer display designed for both PACS and breast imaging applications. It consists of a 30.9" 12 mega-pixel (4200x2800 resolution) LCD panel with integrated LED backlight. The panel is integrated into the display housing body with an internal mechanics chassis structure, that also integrates the electronics, sensors and power supply. The display module is supported by a display stand. Internal sensors and controllers measure, control and stabilize the device. SoftGlow Lights are integrated as an ancillary function for user comfort and can be lit to illuminate the desk and to create some ambient lighting in the reading room.

The Barco Digital Dermatoscope is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners.

The Barco Demetra BDEM-01 is designed to capture images of the skin and optimize the imaging and documentation workflow. The “Barco Demetra BDEM-01” consists of a hardware device and a software application. The hardware device is a portable, battery powered medical device for acquiring and visualizing images of the skin. The device acquires multispectral optical dermoscopic images in a contact mode (device in contact with the skin). In addition, the device can also acquire a clinical close-up image, when it is held at up to 10 to 15 cm from the skin, and a clinical overview image when it is held at a distance of approximately 35-55 cm from the skin. The stand-alone software application is cloud software with a related web application. The cloud software can also generate one or more reports and feedback to the device.

The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The Intuitive Workflow Tools are intended to be used as accessories for image enhancement in diagnostic displays.

The MDCC-6530 is a derivative of the MDCC-6230. ✓ Updated Liquid Crystal Display technology, providing a higher Contrast Ratio ✓ New housing, display stand and internal mechanics ✓ Change in electronics board, including integration of the power supply adaptor into the device ✓ Updated firmware ✓ New packaging The MDCC-4430 only differs from MDCC-6530 in having a 4MP panel instead of a 6MP panel. The Intuitive Workflow Tools package includes some software tools that are intended to support the intended use of the diagnostic displays by performing image enhancement.

The Nio Color 2MP LED Medical Flat Panel Display System is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The display may be used in dental applications.

The MDNC-2123 is a derivative of the MDNC-3421. The modifications are: ✓ Change in LCD panel: INX 2MP panel instead of PSD 3MP panel ✓ Change in chassis housing (light-weight design) ✓ Change in packaging (smaller size) ✓ Change in electronics board ✓ Updated firmware