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Nanox.ARC X is a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, physicists. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions. This device is not intended for mammographic, angiographic, cardiac, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.

Nanox.ARC X is a stationary, floor-mounted, stand-alone digital tomosynthesis system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, from a single tomographic sweep. It serves as an adjunct to conventional radiography, for adult patients in recumbent positions. The system is intended for use in professional healthcare settings such as hospitals, clinics, and imaging centers by trained radiographers, radiologists, and physicists The Nanox.ARC X includes a secured, dedicated off-the-shelf handheld operator console, a multisource, tiltable arc gantry with five identical tubes, a motorized patient table, and a flat panel detector of a scintillator-photodetector type. The image reconstruction service and DICOMization services can be hosted either locally or as part of the secured Nanox.CLOUD, according to customer preference. Nanox.CLOUD also hosts a protocol database service package. The Nanox.ARC X X-ray tubes are operated sequentially, one at a time, generating multiple low-dose images acquired from different angles, during a single sweep, dividing the overall power requirements among the tubes. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions. The acquired projection imaging data is anonymized and automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis image result reduces the effect of overlying structures and provides depth information on structures of interest. The resultant images are re-identified and sent using the DICOM protocol.

Nanox.ARC is a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions. This device is not intended for mammographic, cardiac, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.

Nanox.ARC is a stationary, floor-mounted, stand-alone digital tomosynthesis system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, from a single tomographic sweep. It serves as an adjunct to conventional radiography, for adult patients in recumbent positions. The system is intended for use in professional healthcare settings such as hospitals, clinics, and imaging centers by trained radiologists, and physicists. The Nanox.ARC includes a secured, dedicated off-the-shelf handheld operator console, a multisource, tiltable arc gantry with five identical tubes, a motorized patient table, and a flat panel detector type. The image reconstruction service and DICOMization services can be hosted either locally or as part of the secured Nanox.CLOUD, according to customer preference. Nanox.CLOUD also hosts a protocol database service package. The Nanox.ARC X-ray tubes are operated sequentially, one at a time, generating multiple low-dose images acquired from different angles, during a single sweep, dividing the overall power requirements among the tubes. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions. The acquired projection imaging data is anonymized and automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis reduces the effect of overlying structures and provides depth information on structures of interest. The resultant images are re-identified and sent using the DICOM protocol.

Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists. Digital Tomosynthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions. This device is not intended for mammographic, cardiac, pulmonary, intra-abdominal, intra-cranial, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.

Nanox.ARC is a tomographic and solid-state X-ray system (product codes IZF and MQB) intended to produce tomographic images of the human musculoskeletal system from a single tomographic sweep, as an adjunct to conventional radiography, on adult patients. Nanox.ARC is a floor-mounted tomographic system that consists of a user control console, a multisource, tiltable arc gantry with five alternately-switched tubes, a motorized patient table, a flatpanel detector of a scintillator-photodetector type, and Protocols database and Image processing software packages. Nanox.ARC utilizes several small-sized X-ray tubes that are independently and electronically switched, thereby dividing the overall power requirements over multiple tubes. Nanox.ARC utilizes a tilting imaging ring with five X-ray tubes, operated sequentially, one at a time, used to generate multiple low-dose X-ray projection images acquired from different angles during a single spherical (non-linear) sweep. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions. The acquired projection imaging data is automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis image result reduces the effect of overlying structures and provides depth information on structures of interest. The image reconstruction service, as well as the system's protocol database and DICOMization services, can be hosted either locally or as part of the Nanox.CLOUD, according to customer preference. The resultant images are sent using the DICOM protocol.

The Ortho Device is intended to generate tomosynthesis images of human anatomy for diagnostic purposes of the hand, elbow and foot in patients of all ages. The imaging will provide the physician visualized information about anatomical structures to facilitate assessment in orthopedic cases such as: • Fractures of bones in finger, metacarpus or wrist • Fractures of foot, ankle or elbow joint • Arthritis

The Ortho Device is a 3D tomographic X-ray device intended to be used to produce radiological images of a specific cross-sectional plane of the body. The device is comprised of a Flat Panel X-ray source combined with a digital detector within a mounting frame, a control unit and a workstation. It is intended to offer 3D imaging of orthopedic structures by using a panel of X-ray sources that construct a 3D tomosynthesis image with the associated reconstruction software from individual images; it is also possible to create synthetic 2D images of the desired anatomy. The Ortho Device is a portable system that can be mounted on a stand for tabletop applications or on a trolley cart for added mobility with motorized vertical positioning. The C-Arm and Control Unit components are both designed to be carriable by a single person. To allow for the ideal positioning of the anatomy (hand and weight-bearing foot images) in the beam path and to achieve the desired plane of view, the Ortho Device C-Arm can be manually rotated by up to 90°. The central beam is aligned perpendicularly to the image receptor. The "Ortho Device" was created to fill a diagnostic niche in orthopedic medicine for cost effective and portable imaging for patients and is used, amongst other applications, for 3D-radiographic diagnostic imaging of hand, elbow and foot in orthopedic and radiological practices as well as in emergency departments of hospitals. The Ortho Device results are detailed multi-slice 3D images of patients that allow radiologist interpretation of clinical image data and by this support medical professionals decisionmaking on human anatomy. The Ortho Device system is designed to meet the requirements in accordance with relevant sections of 21CFR 1020.30-1020.31.

The CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures. Applications and techniques: - Gastroenterology - Skeleton - Thorax and lungs - Paediatrics - Urology and gynecology - Emergency/traumatology - Digital angiography - Linear tomography - Auto Image Paste (Stitching) - Tomosynthesis

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The DR 600 system is a General Radiography X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients. In addition, the system provides the Agfa tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in the sitting, standing or lying position. This system is not intended for mammography applications.

The DR 600 with Tomosynthesis is a tomographic and solid state x-ray system (product codes IZF and MQB) intended to capture tomographic slices and static images of the human body. The DR 600 with Tomosynthesis is a ceiling mounted tomographic and general radiographic system that consists of a tube and operator console with a motorized patient table and/or wall stand. The DR 600 with Tomosynthesis uses Agfa's NX workstation with MUSICA2 ™ image processing and flat-panel detectors of the scintillator-photodetector type (Cesium Iodide - CsI or Gadolinium Oxysulfide - GOS). It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

The DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: - Positioning fluoroscopy procedures - Gastro-intestinal examinations - Urogenital tract examinations - Angiography It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-Ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications.

Agfa's DR 800 with Tomosynthesis a tomographic and fluoroscopic x-ray system (product codes IZF and JAA) intended to capture tomographic slices of the human body. The DR 800 is a floormounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table and bucky with optional wall stand, FLFS overlay and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital and wide dynamic range capture. It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

The Discovery XR656 is intended to generate digital radiographic imoges of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications con be performed with the patient sitting, standing, or lying in the prone or supine position and is intended for use in all routine radiography exams. When the VolumeRAD option is included on the system, the system can generate tomographic images of human anatomy including the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. When the VolumeRAD option is used for potients undergoing thorocic imaging, it is indicated for the detection of lung nodules. VolumeRad generates diagnostic images of the chest that aid the radiologist in achieving superior detectability of lung nodules versus posterior-anterior and left lateral views of the chest, at o comparable radiation level. The device is not intended for mammographic applications.

The Discovery™ XR656 with VolumeRAD extended claims remains a radiographic X-ray system capable of generating radiographic and tomographic images of human anatomy. The Discovery XR656 is designed to handle radiographic applications using GE's flat-panel wireless digital detector. The digital detector is comprised of amorphous silicon and cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage. The Discovery XR656 Digital Radiographic Imaging system consists of a Wallstand, elevating table, overhead Tube support, X-ray tube, collimator, system controller, X-ray generator, and wireless/tethered digital detector. Various configurations are available to meet radiographic requirements. The Optima XR640 version of this product does not include advanced applications and uses the tethered version of the digital detector. The Discovery XR656 offers a wide range of advanced clinical applications including GE's VolumeRAD™ (Digital Tomosynthesis), Dual Energy Subtraction, Tissue Equalization and Auto Image Paste. This 510(k) is to expand our marketing claims for lung nodule detection using the VolumeRAD application. There is no change in design, manufacturing, materials or energy source of the already cleared device. All the abilities required to achieve the results of the extended claims during the clinical trial were available at the initial release of the system.

Fujifilm's Tomosynthesis option is intended to acquire tomographic images of human anatomy and to be used with Fujifilm's DR X-ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. It is not intended for mammographic applications.

Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of interest (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.

The Medstone, Radiographic Linear Tomography Option is designed as an optional additional device to the Medstone UroPro 2000 table, intended for use in general radiology. It is designed to enable the production of diagnostic radiologic images of a specific linear cross-sectional plane of the body, eliminating unwanted anatomy and detail by motion blurring of other planes. This device is designed to provide and control the sweep speed and angle of a tomography function to enable the production of a properly imaged X-ray film to accomplish diagnostic imaging of a patient. The table and tomography option are intended to be used by trained professionals, schooled in proper radiology procedures, techniques, positioning and safety.

The Medstone, Radiographic Linear Tomography Option is designed as an 'add-on' optional device to enable the production of radiologic images of a specific linear cross-sectional plane of the body by blurring or eliminating detail from other planes. A high degree of emphasis for the design of this device was placed on error detection and reliability as well as usability and safety.