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The 2430TCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for a mammographic system. It is intended to replace film or screen based mammographic systems in screening mammography. Xmaru W is an integrated software solution indicated for use with the 2430TCA detector.

2430TCA is a digital mammography X-ray detector that is based on flat-panel technology. This mammographic image detector and processing unit consists of a CsI scintillator coupled to a TFT sensor. This device needs to be integrated with a mammographic imaging system. It can be utilized to capture and digitalize X-ray images for mammographic screening. The RAW files can be further processed as DICOM compatible image files by separate console SW, Xmaru W, for a mammographic screening. 2430TCA detector is connected to the viewing station via a LAN cable.

VIVIX-M detectors are flat panel detectors used in mammographic applications to acquire digital images for screening and diagnosis.

VIVIX-M, a series of flat panel detectors models named; FXMD-2430S, with imaging areas of 24cm x 30cm, 18cm x 24cm, respectively. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the Software acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors. These devices should be integrated with an operating PC and an X-Ray generator. It can be utilized to digitalize x-ray images and transfer for radiography diagnostic. VXvue Mammo is a digital X-ray imaging software designed for mammography applications. It acquires, processes, and transmits digital images from VIVIX-M detectors (FXMD-1008S and FXMD-2430S) while ensuring compliance with DICOM standards for seamless integration with PACS and other medical systems.

The digital mammography system MAMMOMAT B.brilliant is intended to be used for mammography exams, screening, diagnosis, biopsies and dual energy procedures under the supervision of medical professionals. Mammography images can be interpreted by either hard copy film or soft copy workstation. With Biopsy Option: The InSpect feature for MAMMOMAT B.brilliant with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.

MAMMOMAT B.brilliant is a floor-mounted, full field digital mammography system for screening, diagnostic, and biopsy procedures on standing, seated, or recumbent patients. The system consists of an examination stand with x-ray generator, a gantry with tube housing assembly, and mammography support table, including detector and an acquisition workstation with a radiation shield. The MAMMOMAT B.brilliant comes with a variety of compression plates and a biopsy attachment for diagnostic adjunct procedures. The MAMMOMAT B.brilliant features an updated detector, a new image acquisition chain (tube, filter, collimator) and improvements to the image acquisition workflow and biopsy workflow. Adaptations have been made to the image processing due to the new image acquisition hardware and the Soft- and hardware feature improvements. Patient positioning features like a head rest have been added.

The RMF-2000 generates 2D digital mammography images. The RMF-2000 is intended to be used for screening and diagnosis of breast cancer. This unit is intended for use in the same clinical applications as traditional screen film mammography systems.

The system consists of a gantry with integrated high-voltage generator as well as an optional radiation shield with a height-adjustable control desk with an integrated Acquisition Workstation (AWS). The moveable swivel C-arm on the gantry contains the X-ray tube on the top end and the breast support with the X-ray detector on the bottom end. The detector is a full field digital mammography detector. RMF-2000 acquires digital mammographic images for diagnosis of the breast cancer. RMF-2000 is designed to be used in the same clinical application for 2D screening mammographic systems. The screening examination exposes X-rays to the left and the right breasts of the patient to acquire images. Also, the RMF-2000 can be used to additional precision diagnosis for breasts. The device's software provides an integrated solution for X-ray projection. It integrates with the X-ray generator and the digital detector and acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer.

The Planmed Clarity 2D and S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D and S systems are intended to be used for screening and diagnosis of breast cancer. The Planmed Clarity 2D and S systems may also be used for additional diagnostic workup of the breast. Additionally, the Planmed Clarity 2D and S systems can be used to provide digital x-ray images of breast biopsy specimens.

The Planmed Clarity 2D and Clarity S are Full Field Digital Mammography (FFDM) systems for generating mammographic x-ray images that can be used for screening and diagnosis of breast cancer. Planmed Clarity 2D and Clarity S utilize an amorphous silicon based digital image receptor to capture images. The receptor directly converts the incoming X-ray photons to digital image data. The workflow with Clarity 2D is controlled by the side displays/touch panels and the workflow of Clarity S is controlled from the acquisition workstation and Clarity Manager acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS, respectively), as a format of modality worklist. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.

The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems. Dual energy procedures is an optional feature of the ASPIRE Cristalle that can capture images consecutively under two different tube voltage conditions during one compression, and then create and display a subtraction image of the two acquired images. This optional feature shall enable contrast enhanced breast imaging and is used as an adjunct following mammography. Dual energy procedures is not intended for primary screening or diagnosis.

The ASPIRE Cristalle (K173132) (FDR MS-3500) is an integrated FFDM system combining an X-ray system made by Fuiifilm's a-Se detector and Acquisition Workstation (AWS). The ASPIRE Cristalle creates digital mammography images by direct capture of x-ray energy using the a-Se detector. The detector is a Fujifilm design utilizing an a-Se photoconversion layer with TFT Readout circuitry to acquire image data and transfer images to the A WS for automated post processing, technologist preview and QC, and subsequent transmission to hard copy printers, diagnostic workstations and archiving systems. The ASPIRE Cristalle provides powered compression and three AEC modes. The ASPIRE Cristalle Acquisition Workstation (FDR 3000AWS) includes an off the shelf personal computer, the application software, Windows Operating System, a 5megapixel portrait type monitor, and a hub. The hub transmits signals between the personal computer and control cabinet, and between the personal computer and exposure stand. The AWS display primarily consists of three windows: - . Patient Information Input window - Exposure Menu Selection window ● - . Study window. The user may switch between these windows depending on the operation being performed. The X-ray control panel, which controls and observes the exposure stand, is always displayed in the lower part of each window. This allows setting the exposure conditions and confirming the radiation conditions on a single view. This 510(k) submission introduces the optional feature of Dual energy procedures for the ASPIRE Cristalle. Dual energy procedures can capture images consecutively under two different tube voltage conditions during one compression, and then create and display a subtraction image of the two acquired images. This optional feature shall enable contrast enhanced breast imaging and is used as an adjunct following mammography. It should only be used with FDA approved contrast agents according to the manufacturer's instructions. The X-ray exposures must be performed after the contrast agent has diffused into the breast and before its washout, which is typically between 2 to 7 minutes after beginning of injection according to Clinical publications and/or the manufacturer's instructions. For the image acquisition in one direction, it takes about 25 seconds from the first X-ray exposure to the display of energy subtraction images.

The Digimamo D ® Full-Field Digital Mammography System is a device intended to produce planar digital x-ay images of the entire breast. The Digimamo D is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Digimamo D is intended to be used in the same clinical applications as traditional film/screen systems.

This is a mammography system available in only a digital version. The main characteristics are: Operation Panel/Console, X-ray tube information, Filter Selection, Window Material and thickness, Focal Spot Sizes, Operating principle, Radiological Characteristics, Column and Gantry, Flat Panel Detector, Workstation.

Helianthus is intended to produce two dimensional digital mammographic images of the breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy.

Helianthus is a mammography solution composed of equipment and software for different examination types and optimized for digital imaging. Helianthus is a digital mammography system also called full-field digital mammography (FFDM) system. It is an integrated system that includes both the X-ray delivery system and integrated detector. It consists of an x-ray generator, x-ray control, x-ray tube, collimator, beam filter, breast compression system, grid, image receptor system, and accessories. The image receptor system consists of a built-in full-filed solid state detector, acquisition software, acquisition work station (AWS), and accessories. It includes an optional stereotactic biopsy device (BYM 3D DMD) with its respective Operator's Manual. Helianthus is intended to produce two-dimensional digital mammographic images of the breast for diagnosis of breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy

The Senographe Pristina system is intended to be used in the same clinical applications as traditional mammographic film/ screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.

eContrast is an image post-processing algorithm applied to the DICOM "for processing" images in order to generate “for presentation" images. It consists in optimizing the local contrasts while reducing the overall dynamic range. This submission is proposing a software modification consisting of a new version of eContrast algorithm for Senographe Pristina platform to allow more flexibility for proposing different levels preserving/enhancing the visibility of the different structures present in the breast image. The first version of the eContrast image processing was previously cleared for Senographe Essential platform in the 510(k)# K131885. Then it was cleared with Senographe Pristina platform in the 510(k) # K162268. This design change is a software and labeling only option, compatible with Senographe Pristina installed base and does not require any hardware modification on the Senographe Pristina platform.