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The MOZART® Supra® Specimen Tomosynthesis System is a cabinet X-ray system that is used to provide 2-dimensional and 3-dimensional tomographic digital X-ray images of harvested specimens from various anatomical regions.

The MOZART SUPRA (XPERT84) Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens both in two-dimensional and three-dimensional tomosynthesis views. - It is the only cabinet specimen imaging system to utilize 3-D Tomosynthesis technology. - Creates images in 1mm digital slices of the specimen, allowing physicians to evaluate the specimen layer by layer. Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of inters (ROI). To produce these slices multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices. Tomosynthesis provides visualization of human anatomy by - 1. Removing overlying anatomical structures, which could otherwise obscure a structure of interest by superimposition in a two dimensional presentation, and - 2. Producing a number of slice images throughout the entire volume of the anatomy The exceptionally high magnification capability (up to 5X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 30 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software. To support the Tomosynthesis application, the predicate device, MOZART SUPRA (XPERT84), K200756, has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monoblock X-ray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and an Amorphous Selenium detector mounted stationary in the bottom of the cabinet xray unit

The MOZART (XPERT42) is a Cabinet x-ray system that is used to provide two dimensional and three dimensional tomographic digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. It is not used for mammography

The MOZART Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens both in two-dimensional and three-dimensional tomosynthesis views. It is the only cabinet specimen imaging system to utilize 3-D Tomosynthesis technology. Creates images in 1mm digital slices of the specimen, allowing physicians to evaluate the specimen layer by layer. It has been clinically proven for the following: Provides more anatomical information than single planar 2-D imaging alone. The subject x-ray cabinet system Kubtec Mozart Xpert 42 is not intended for mammography. Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of inters (ROI). To produce these slices multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices. Tomosynthesis provides visualization of human anatomy by Removing overlying anatomical structures, which could otherwise obscure a structure of interest by superimposition in a two dimensional presentation, and Producing a number of slice images throughout the entire volume of the anatomy. The exceptionally high magnification capability (up to 5X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 30 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software. To support the Tomosynthesis application, the predicate device, MOZART (XPERT42), has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monoblock Xray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and an Amorphous Selenium detector mounted stationary in the bottom of the cabinet x-ray unit.

The Kubtec XPERT 80 is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. It is not used for mammography

The XPERT 80 Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 5X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 30 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software. It has been designed to comply with 21 CFR 1020.40.

The MOZART SUPRA Specimen Tomosynthesis System is a Cabinet x-ray system that is specifically designed to provide high detail radiographic imaging of surgically excised medical specimens from various anatomical regions, i.e. breast, both in 2-dimensional and 3-dimensional tomosynthesis views.

The MOZART SUPRA(XPERT84) Specimen Radiography System is a Cabinet X-ray System specifically designed to provide 3-D high detail radiographic imaging of surgically excised medical specimens utilizing tomosynthesis. The MOZART SUPRA(XPERT84) is a fully self-contained and shielded cabinet system equipped with a 90kVp micro-focus x-ray source and a 10'' x 12" 49.5 micron high resolution CMOS Digital Detector. It is the only cabinet specimen imaging system to utilize 3-D Tomosynthesis technology. Creates images in 1mm digital slices of the specimen, allowing physicians to evaluate the specimen layer by layer.

The MOZART(XPERT42) is a Cabinet x-ray system that is used to provide two dimensional and three dimensional tomographic digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.

The MOZART Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimensional and threedimensional tomosynthesis views. - It is the only cabinet specimen imaging system to utilize 3-D Tomosynthesis technology. ● - . Creates images in 1mm digital slices of the specimen, allowing physicians to evaluate the specimen layer by layer. Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of inters (ROI). To produce these multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices. To support the Tomosynthesis application, the predicate device, XPERT 40, has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monoblock X-ray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and the same CMOS detector mounted stationary in the bottom of the cabinet x-ray unit. To support the Tomosynthesis application, the proposed device, MOZART, utilizes the predicate device, XPERT 40, having the addition of a low-voltage screw-drive linear actuator installed in the enclosed head of the cabinet, which ensures operator safety, with the same 50 kVp monoblock X-ray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and the same CMOS detector mounted stationary in the bottom of the same shielded cabinet x-ray unit with proprietary software installed into an off the shelf personal computer, Microsoft Windows 7 Operating System, and a 2 megapixel or greater portrait type monitor. The workstation on the MOZART utilizes a more powerful GPU to facilitate the handling of the collected projection data. It utilizes a method of dynamically reconstructing 3D tomographic images from a set of projections images. This includes loading the set of projection images into memory, selecting a region of interest, applying any necessary preprocessing, selecting a reconstruction method reconstructing an image according to said reconstruction method to produce a 3D tomographic image focusing on said region of interest, performing any post reconstruction processing on the 3D tomographic image and rendering said 3D tomographic image on a display. US Patent US 8,233,690 B2 displaying the complete algorithm and process is included.