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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 Uroview FD II is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray-diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological treatment, planning and diagnostic procedures including but not limited to: - · Querying and retrieving patient information and /or images from other modalities. - · X-ray examination of the urogenital area (e.g. cyctoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements. - · Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum. - · Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy). - · Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy). - · Laparoscopy (e.g. cholecystectomy, lymph node dissection, abdominal testis detection/correction. varicocele). - · Application of fistula (kidney/bladder). - · Simple procedures (e.g. urethra, testis, phimonis). - · Introcorporeal shock wave lithotripsy. - · Uroflow/urodynamics. - · Pediatric radiological and therapeutic applications

The Uroview FD II is a solid state detector fluoroscopic, X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The basic unit is a cantilevered, continuously adjustable, isocentric tilting patient the Uroview FD Skeleton, which can be raised and tilted to provide convenient access for the patient as well as optimum and ergonomic operating conditions for the user. The Uroview FD II X-ray system is a completely mounted system and is equipped with a digital imaging system with a dynamic flat detector, designed to replace traditional spot film devices using screen-film cassettes or "CR" plates and fluoroscopy with image intensifier CCD cameras. The system is also equipped with a generator and automatic, multilayer, square field collimation system intended for installation on stationary X-ray equipment. A rotating anode X-ray tube is mounted. The measuring chamber is placed between the patient and the detector in order to detect the actual dose value for the automatic exposure control (AEC), to provide consistent x-ray film appearance and to guarantee error-free images even at low kV values. Attenuation factor is low and X-ray scattering is reduced to minimum by using a moveable grid. The Uroview FD II X-ray system includes the following major components: - . Uroview FD Skeleton (urological table incl. tilting table) - High Frequency RF X-ray generator - X-ray tube incl. housing - Collimator - . Measuring chamber - . Grid - Dynamic flat panel detector - Digital imaging workstation - . Video monitors - Accessories The Uroview FD II is considered as an update to the model Uroview FD with some new components as part of the continuous X-ray system evolution. Major X-ray components are identical to the Uroview FD and new components use FDA-cleared or FDA-registered X-ray components. Therefore the Uroview FD II is considered similar by properties and technological characteristics. The Uroview FD II system is designed to meet the requirements in accordance with relevant sections of 21 CFR 1020.30-1020.33.

The Uroview FD is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray-diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/ urologic treatment table, may be used for urological treatment, planning and diagnostic procedures including but not limited to: · Querying and retrieving patient information and /or images from other modalities. · X-ray examination of the urogenital area (e.g. cyctoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements. · Ultrasound examinations(in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum. · Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement , penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy). · Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy). · Laparoscopy (e.g. cholecystectomy, lymph node dissection, abdominal testis detection/correction, varicocele). - · Application of fistula (kidney/bladder). - · Simple procedures (e.g. urethra, testis, phimonis). - · Introcorporeal shock wave lithotripsy. - Uroflow/urodynamics. - · Pediatric radiological and therapeutic applications.

The "Uroview FD" is a solid state detector fluoroscopic, X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The basic unit is a cantilevered, continuously adjustable, isocentric tilting patient table called the "Uroview FD Skeleton", which can be raised and tilted to provide convenient access for the patient as well as optimum and ergonomic operating conditions for the user. The Uroview FD X-ray system is a completely mounted system and is equipped with a digital imaging system with a dynamic flat detector, designed to replace traditional spot film devices using screen-film cassettes or "CR" plates and fluoroscopy with image intensifier CCD cameras. The system is also equipped with a generator and automatic, multilayer, square field collimation system intended for installation on stationary X-ray equipment. A rotating anode X-ray tube is mounted. The measuring chamber is placed between the patient and the detector in order to detect the actual dose value for the automatic exposure control (AEC), to provide consistent x-ray film appearance and to guarantee error-free images even at low kV values. Attenuation factor is low and X-ray scattering is reduced to minimum by using a moveable grid. The Uroview FD X-ray system includes the following major components: - . Uroview FD skeleton (urological table incl. tilting table) - . High Frequency RF X-ray generator - X-ray tube incl. housing - . Collimator - . Measuring chamber - . Grid - . Dynamic flat panel detector (Pixium RF4343 FL, originally cleared under K080859) - . Digital imaging workstation - Video monitors - . Accessories The Uroview FD X-ray System includes the following two software programs: HIRIS RF43 and Uroview FD software; these are explained briefly. The Hiris RF43 software controls the digital imaging system in fluoroscopy and radiography modes using the flat panel detector. The software is specifically designed for remote controlled fluoroscopy and radiography and emergency equipment and performs real-time X-ray diagnostics of the gastro-intestinal tract and the urogenital system. The Uroview FD software controls the patient table Uroview FD (Skeleton) and does not interact with the HIRIS RF43 software. It allows the user comprehensive control of the patient table via hand control and foot switch allowing operator to activate movement of the Uroview FD. The Uroview FD system is designed to meet the requirements in accordance with relevant sections of 21CFR 1020.30-1020.33.