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The MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) is intended to be used in the same clinical applications as traditional film/screen systems.

This application is to add functionality to the previously cleared MicroDose SI, Model L50, (K123995) that allows for breast density measurements. The L50 submission described that the detector electronics have been modified to do spectral imaging through the functionality to discriminate between high and low energy photons based on an energy threshold. The first application of this technology is Spectral Breast Density Measurement where breast glandularity and thickness is measured simultaneously by the spectral difference in X-ray attenuation between adipose and fibroglandular tissue. The MicroDose'Sl can thereby measure volumetric glandularity and breast thickness for each pixel in the image. Total breast volume is calculated by integrating the breast thickness over the breast region. taking pixel size and beam geometry into account. Fibroglandular thickness is calculated as the product of breast thickness and volumetric glandularity for each pixel. Total fibroglandular volume is then calculated by integrating the fibroglandular thickness over the breast region. The total breast volumetric glandularity is then given as the ratio of fibroglandular to breast volume. The correlation between the MicroDose Density Score and the radiologist's BI-RADS score has The following Information is sent as part of the content of a DICOM Structured Report, SR, to selected destinations (for example a PACS). Breast analysis information is also included as private attributes in the DICOM header of the acquired images.

The MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) is intended to be used in the same clinical applications as traditional film/screen systems.

The MicroDose SI (model L50) is a full-field digital mammography system comprised of an image acquisition system, a gantry and an acquisition workstation computer equipped with a keyboard, a keypad, a mouse, and a monitor. The image acquisition system includes a digital detector of photon counting technology, x-ray tube (with tungsten target and aluminum filtration), high voltage generator, compression paddle(s), and multi-slit collimator. The acquisition workstation is the user interface for preparing and initiating image acquisition, image processing, and image transfer to the desired destination (e.g. PACS) for diagnosis and archiving. The MicroDose SI (model L50) detector is based on photon counting technology and consists of a large number of crystalline silicon strip detectors. The technology enables high detection efficiency of photons and efficient rejection of electronic noise. The MicroDose SI (model L50) uses a multi-slit scanning technique that prevents image degradation caused by scattered radiation by removing photons scattered in the breast and not directed towards the detector. These factors combine into a dose efficient system. The MicroDose SI (model L50) provides three exposure modes; manual, automatic (parameters predefined based on compressed breast thickness), and SmartAEC continuously adjusts the exposure based on measured transmission from the leading detector edge. The changes compared to the L30 model involves a minor modification to the collimator, such that the range of breast thickness that can be imaged on the device is slightly expanded.

The Philips MicroDose L30 is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Philips MicroDose L30 is intended to be used in the same clinical applications as traditional film/screen systems.

The Philips MicroDose L30 is a full-field digital mammography system comprised of an image acquisition system, a gantry and an acquisition workstation computer equipped with a keyboard, a keypad, a mouse, and a monitor. The image acquisition system includes a digital detector of photon counting technology, x-ray tube (with tungsten target and aluminum filtration), high voltage generator, compression paddle(s), and multi-slit collimator. The acquisition is the user interface for preparing and initiating image acquisition, image processing, and image transfer to the desired destination (e.g. PACS) for diagnosis and archiving. The Philips MicroDose L30 detector is based on photon counting technology and consists of a large number of crystalline silicon strip detectors. The technology enables high detection efficiency of photons and efficient rejection of electronic noise. The Philips MicroDose 130 uses a multi-slit scanning technique that prevents image degradation caused by scattered radiation by removing photons scattered in the breast and not directed towards the detector. These factors combine into a dose efficient system. The Philips MicroDose 130 provides three exposure modes; manual, automatic (parameters predefined based on compressed breast thickness), and SmartAEC continuously adjusts the exposure based on measured transmission from the leading detector edge.