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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.

The DIGIVIEW 395, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.

The DIGIVIEW 395 is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:TI scintillator. The DIGIVIEW 395 detector has an active area of 43.2 cm x 35.5 cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi. The detector can be integrated into a fixed room X-ray system to enable digital radiography.

The Kub250 is intended for us by a qualified/trained physician or technician for generating, and displaying diagnostic radiographic images of neonatal patients. The Kub250 is not intended for mammography applications.

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The Digiview 250 is indicated for use in generating radiographic images of human anatomy. The device is intended to provide digital x-ray image capture for conventional film/screen radiographic examinations and replace radiographic film/screen systems in all general purpose diagnostic procedures. The device is not intended for mammography applications.

The Kubtec Digital Radiography DIGIVIEW 250 ® is a CMOS based solid state x-ray imager which has a 192 x 246 mm imaging area. The Digital Radiography DIGIVIEW 250® imager intercepts X-ray photons after they pass through anatomy and surrounding air and converts the X-ray photons into electrical signals. These resultant electric signals are converted into digital values which are transmitted for remote viewing. The DIGIVIEW 250 ® system features a DICOM 3.0 compliant software, DIGICOM. The DIGICOM software enables the display and analysis of x-ray images; either live (real time) or previously captured and the storage and transmission of these images to PACS systems.

Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.

The XPERT Specimen Radiography System is a self contained, shielded cabinet x-ray system designed to meet imaging requirements for surgically excised and needle core biopsies. This device does not expose the patient to radiation, it is used for biopsy tissue samples only. The system design features an x-ray source that produces a high resolution, 5 -45 micron focal spot. The control system, coupled with a touch panel screen for operator interface. The XPERT system features a DICOM 3.0 compliant DIGICOM computer and software application. The DIGICOM enables the display and analysis of x-ray images, either live (real time) or previously captured, and the storage and transmission of these imagines to the PACS.

Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.

The XPERT Specimen Radiography System is a self contained, shielded cabinet x-ray system designed to meet imaging requirements for surgically excised and needle core biopsies. This device does not expose the patient to radiation, it is used for biopsy tissue samples only. This equipment provides high resolution, high contrast, X-ray images, using either radiographic file up to 10x12" or digitally with the DICOM compliant DIGIVIEW digital detectors up to 8x10" in size. With its small focal spot x-ray source and adjustable sample positioning capability, the XPERT 40 provides variable magnification for increased visibility and sharpness of detail for lesions and abnormalities in biopsies. The device is provided with a PC including the DICOM compliant software and an LCD monitor for high resolution imaging.