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The VALORY 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 adults and pediatric patients. Applications can be performed with the patient in sitting, standing or lying position. The system is not intended for use in Mammography applications

VALORY is a solid state x-ray system, a direct radiography (DR) system (product code MQB) intended to capture general radiographic images of the human body. VALORY is a ceiling mounted stationary X-Ray system with digital image capture that consists of a tube and operator console with a patient table and/or wall stand. VALORY uses Agfa's NX workstation with MUSICA2 TM image processing and flat-panel detectors of the scintillator-photodetector type (Cesium Iodide - CsI) to capture and process the digital image.

The DR 800 with DSA 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 - · Digital Subtraction Angiography It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for projection 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. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Not intended for cardiovascular and cerebrovascular contrast studies. Not intended for mammography applications.

Agfa's DR 800 with DSA medical device is a fluoroscopic x-ray system that includes digital angiography (product code JAA) intended to capture tomographic, static and dynamic images of the human body. The DR 800 is a floor-mounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table. FLFS overlay and bucky with optional wall stand and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital, wide dynamic range and angiographic image 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. This submission is to add the newest version of the DR 800 with Digital Subtraction Angiography (DSA) to Agfa's radiography portfolio.

Agfa's DX-D Imaging Package with XD Detectors is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of the human anatomy. The DX-D Imaging Package with XD Detectors may be used wherever conventional screen-film systems may be used. Agfa's DX-D Imaging Package with XD Detectors is not indicated for use in mammography.

The DX-D Imaging Package, previously cleared under K142184, is a solid state x-ray system, a direct radiography (DR) system (product code MQB) intended to capture general radiographic images of the human body. It is a combination of Agfa's NX workstation with MUSICA TM image processing and one or more flat-panel detectors of the scintillator-photodetector type (Cesium Iodide - CsI or Gadolinium Oxysulfide - GOS). It is capable of replacing other direct radiography, including computed radiography systems with conventional or phosphorous film cassettes. This submission is to add the XD Detectors (XD 10/10+, XD 14/14+ and XD 17/17+) Flat Panel Detectors to Agfa's DX-D Imaging Package portfolio. Agfa's XD Detectors are currently marketed by Vieworks Co. Ltd. as FXRD-4343VAW/VAW Plus. FXRD-3643VAW/VAW Plus. and FXRD-2530VAW/VAW Plus which is the predicate for this submission (K200418). The optional image processing allows users to conveniently select image processing settings for different patient sizes and examinations. The image processing algorithms in the new device are identical to those previously cleared in the DX-D Imaging Package - DX-D 40 (K142184reference) device and other devices in Agfa's radiography portfolio today. The addition of the offline workflow is identical to the Vivix-S VW (K200418) predicate device. Principles of operation and technological characteristics of the new, predicate and reference devices are the same. There are no changes to the intended use/indications of the device. The new device is physically and electronically similar to the predicate device (K200418) which includes the addition of an offline workflow capable of storing up to 200 images on the flat-panel detector for later viewing. It uses the same NX workstation with MUSICA™ image processing as the reference device (K142184) and the same flat panel detectors of the scintillator-photodetector type (Cesium Iodide - Csl or Gadolinium Oxysulfide - GOS) to capture and digitize the images as the predicate device (K200418). Laboratory data and image quality evaluations conducted with internal specialists confirm that performance is equivalent to the predicate. Differences in devices do not alter the intended diagnostic effect nor do they impact the safety and effectiveness of the device.

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 100s system is a mobile X-ray imaging system used in hospitals, clinics and medical practices by radiographers and radiologists 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. Applications can be performed with the patient in the sitting, standing or lying position. This device is not intended for mammography applications.

Agfa's DR 100s is a mobile x-ray system, a direct radiography system (product code ILL) intended to capture images of the human body. The device is an integrated mobile digital radiography x-ray system. The complete DR 100s systems consists of the mobile x-ray unit with integrated x-ray generator and NX software and one or more DR detectors. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital image capture. It is compatible with Agfa's computed radiography systems as well. This submission is to add another mobile unit to Agfa's direct radiography portfolio. The optional image processing allows users to conveniently select image processing settings for different patient sizes and examinations. The image processing algorithms in the new device are identical to those previously cleared in the DX-D 100 (K103597) and other devices in Agfa's radiography portfolio today, which includes DR 600 (K152639), DR 400 (K141192) and DR 800 (K183275). Significant dose reduction can be achieved using the DR 100s with patented Agfa's MUSICA imaging processing and CsI flat-panel detectors. Testing with board certified radiologists determined that Cesium Bromide (CR) and Cesium Iodine (DR) detectors when used with MUSICA imaging processing can provide dose reduction between 50-60% for adult patients and up to 60% for pediatric and neonatal patients when compared to traditional Barium Fluoro Bromide CR systems (K141602). Principles of operation and technological characteristics of the new and predicate device are the same. The new device is virtually identical to Agfa's DX-D 100(K103597) with the exception that it has a telescopic column and ergonomic design. It uses the same flat panel detectors to capture and digitize the image. Differences in devices do not alter the intended diagnostic effect.

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.