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The System is intended for use in Radiographic / Fluoroscopic applications including general radiographic / fluoroscopic diagnostic, and interventional X-Ray imaging for General and Pediatric Populations.

The Soteria E-View system is classified as an interventional fluoroscopic X-ray system. The fundamental performance characteristics of the Soteria E-View interventional fluoroscopic X-ray system consists of: - The patient table and C- arm with X-ray source on one side and the flat panel detector on the opposite side. The C-arm can be angulated in both planes, and the flat panel detector can be lifted vertically. The tabletop can be shifted from side to side and move forward/backward by an operator. - Real-time image visualization of patient anatomy during procedures. - Imaging techniques and tools to assist interventional procedures. - . Post-processing functions after interventional procedures. - Storage of reference/control images for patient records. - Compatibility to images of other modalities via DICOM. - . Built-in radiation safety controls-with the already FDA cleared CA-100S /FluoroShield (K182834). This array of functions provides the physician with the imaging information required to achieve minimally invasive interventional procedures. The Soteria E-View system is available as a Model GI-100 configuration. It is similar to the currently marketed predicate Soteria.Al consisting of an X-ray generator, image processor, collimator, X-ray Tube, Positioner, and patient table with CA-100S / FluoroShield Accessory, (K212336).

The Adora DRFi is a direct radiography and radioscopy, universal and permanently installed diagnostic X-ray system with a flat panel detector, which allows the acquisition of a wide range of Xray examinations. It is intended for use in generating diagnostic and radioscopic images of human anatomy. The Adora DRFi X-rav system is intended for use by trained and qualified personnel at the entire body of both adult and pediatric patients, and exposures may be acquired with the patient in supine, standing or sitting positions as well as with the patient in e.g., a wheelchair or on a stretcher. Radiographic procedures can take place with the detector in free position as well as fixed in the docking station: whereas radioscopic procedures may only take place when the detector is fixed in the docking station. The Adora DRFi is not for mammography examinations.

The Adora DRFi x-ray system is a ceiling suspended universal x-ray system using direct radiography and radioscopy on flat panels for diagnostic purposes. The system can be used for acquisition of a wide range of radiographic and radioscopic x-ray examinations of the whole body, on both adult and pediatric patients. The patients may be lying on the Adora table, in a hospital bed or on a stretcher, using the flat panel's ability to be placed either inside or outside its housing for radiographic examinations. Radioscopic examinations, however, can only be made with the flat panel in the housing suspended in one of the two telescopes. The patients may also be standing on the floor, sitting on a chair or in a wheelchair. Examinations which can be performed on Adora X-ray systems; Radiography for Pelvis Supine, Pelvis Standing, Knee, and Radioscopy for Esophagus, Tube placement, knee. The positioning of the ceiling suspended X-ray tube and the flat panel relative to the patient and each other are controlled by the operator, either through a joystick or via pre-programmed auto-positions activated by the operator. The Adora X-ray system is a main powered, permanently installed system for use in hospitals and x-ray clinics and is intended solely for use by healthcare professionals, trained in and qualified for the use of medical xray equipment for diagnostic purposes.

The Trident Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

The Trident Mobile Fluoroscopy System is a mobile Image Intensified Fluoroscopic X-ray unit with a flat panel image receptor system. The Trident Mobile Fluoroscopy System consists of the following components: an X- ray generator and tube housing and a flat panel detector. An X-ray cabinet contains system elements such as the X- ray generator, power electronics for the imaging chain. The system offers an optional monitor for viewing the captured images. The X-Ray Generator is located in the base of the C-Arm. High voltage is carried to the X-Ray tube across a set of cables and the X-Ray tube emits the X-Rays that are directed toward the control of the operator. The X-Rays pass through the patient and are captured by the flat panel image detector (FPD). The flat panels used in the Trident Mobile Fluoroscopy System are Varex models 3030DX or 2121DXV. This Varex series have been used in similar cleared devices (K192541, K220871). The Varex flat panel system used in the Trident uses Cesium lodide as the image scintillator which is identical to that used in the reference device (K220871). These flat panel models differ only in the dimensions of the image receptor. FPD images are processed and can be displayed on the optional image monitor located on the Workstation. The Physician or system operator can view the images as they are displayed on the attached monitor or they may also choose to store the images for later review via the connection to the hospital DICOM system. The C-Arm is designed to move into the required positions to allow for proper x-ray locations in relation to the patient for the procedure that is being performed. These procedures can be performed with or without a patient table. In order to accomplish this, the system is designed with the ability to rotate/swivel to obtain different appropriate viewing angles. The systems movement is manually adjusted with the exception of the z-axis. This is motorized with the controls on the C-arm. The release of x-ray is controlled using a footswitch and/or a hand controller.

ProxiDiagnost N90 / Precision CRF is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, Substantial Equivalent (SE) date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a multi-functional general Radiography/ Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography. Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a nearby controlled fluoroscopy system in combination with high-end digital radiography system consisting of a floor-mounted tilt adjustable patient support table and a scan unit consisting of a tube and a flat panel dynamic detector, Pixium FE4343F, for the fluoroscopy examinations. The tabletop can be moved by a motor in the lateral and longitudinal direction and can be tilted at -85° to +90° degrees. The scan unit tilts with the table and can be moved in the longitudinal and lateral direction, relative to the table and to the patient. The system is suitable for routine X-ray examinations and fluoroscopy examinations on patients in standing, seated, or lying positions. Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF retrieves images by means of a Cesium Iodide flat panel detector. Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF consists of the Basic unit ("geometry" or "table unit"), Workstation Eleva Workspot (with integrated generator control, hand switch, keyboard, mouse, touch screen and PC), dual screen-monitor, Spot film device (digital camera or flat panel detector). Fixed Detector (Fluoroscopy). X-ray Generator for R/F applications, X-ray tube assembly. The optional components like wireless portable detectors small and large, Bucky tray for wireless portable detectors SkyPlate detector, Ceiling Suspension, Fixed Vertical stand, Ceiling Suspension for monitors, monitor trolley, Remote control for R/F (Radiography-fluoroscopy) viewer, accessories for "Stitching Stand", are also available. Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the Eleva software of the proposed ProxiDiagnost N90 / Precision CRF is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Backend (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images. The accessories for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837). The list of the accessories for the proposed ProxiDiagnost N90 / Precision CRF: - Footrest ● - Hand Grips 0 Radiation Protection Accessories - Flexible Radiation Protection Apron 0 - Front Radiation Protection Apron ● Additional Accessories (Optional) - Monitor Trolley ● - Monitor Ceiling Suspension - Parking Frame for Accessories ● - Shoulder Support ● - Side bar ● - Compression Belt ● - Adjustable Lateral Cassette Holder - Leg Supports - o Infusion Bottle Holder - Arm Support for Catheterization - Ankle Clamps - Overhead Hand Grip - Adult Headrest - Mattress - Rotatable Stool for Footrest - Pediatric Micturition Set - Stretch Grip for Wall Stand - Bar Code Scanner o - Patient Support ● - o Stitching Ruler Accessories for the SkyPlate Detector (Optional) - Mobile Detector Holder ● - Detector Holder Patient Bed ● - Portable Panel Protector ● - Detector Handle ● - WPD Bags ● - o Grids for SkyPlate Detector large The Components for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837). The list of the Components for the proposed ProxiDiagnost N90 / Precision CRF: - Eleva Workspot and RF Viewer ● - UPS for Eleva Workspot (Optional) ● - Table ● - Indication Box ● - Foot Switch - Ceiling Suspension Motorized CSM3 (Optional) ● - Wall Stand (Vertical Stand VS2) (Optional) - SkyPlate / Portable Detector (Optional) 0 The proposed device complies to 'Guidance for the Submission of 510(k)'s for Solid State Xray Imaging Devices, dated September 1, 2016'. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K212837). Also, other image chain components like Xray tube and generator, which are used for exposure characteristics and clinical performance evaluation remains the same. Hence all the features and characteristics potentially influencing image quality of the proposed are in accordance with FDA guidance document. Additionally, image quality testing has been performed on the proposed device for the changes that are affecting the image quality.

The CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

The CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography. The CombiDiagnost R90 is a remote-controlled fluoroscopy system in combination with high-end digital radiography. The system is suitable for routine X-ray examinations and special examinations on patients in standing, seated or laying positions. The CombiDiagnost R90 retrieves images by means of a Cesum Iodide flat panel detector. Philips fluoroscopy systems consist of the following components (standard configuration): - Basic unit (also called "geometry" or "table unit") - Workstation Eleva Workspot with integrated generator control, hand switch, keyboard, mouse, touch screen and PC - Equipped with a dual screen-monitor as standard - Spot film device (digital camera or flat panel detector) - X-ray Generator Velara - X-ray tube assembly mounted in above table mode to be remote controlled - Receptor: Flat panel detector Optional components: - Skyplate wireless portable detectors small and large - Ceiling Suspension (CSM3) - Vertical Wall stand (VS2) - Ceiling Suspension for monitors - Monitor trolley - Remote control for RF viewer - Accessories for "Stitching on the Table" The CombiDiagnost R90 uses the same workflow from the currently marketed and predicate device, CombiDiagnost R90 (K163210) with only the following modifications: - additional optional components (like the reference monitor, remote control), - Eleva Workspot updated to incorporate new imaging features mainly from the previously approved reference device, DigitalDiagnost C90 (K182973) along with functional clusters like Digital Subtraction Imaging and stitching on the table - updates to improve usability and serviceability. The Eleva software of the proposed CombiDiagnost R90 is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Back-end (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images. The proposed CombiDiagnost R90 is same as the predicate device (K203087) with some modifications as described. The proposed device complies to 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, dated September 1, 2016'. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K203087). Also, other image chain components like X-ray tube and generator, which are used for exposure characteristics and clinical performance evaluation remains the same. Hence all the features and characteristics potentially influencing image quality of the proposed are in accordance with FDA guidance document. Additionally, image quality testing has been performed on the proposed device for the changes that are affecting the image quality.

The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Alphenix series systems, Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging of selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity). When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used with selective catheter angiography procedures for the heart, chest abdomen, pelvis and brain.

The XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 is used for images input from Diagnostic Imaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation.

The Dornier Nautilus is an image intensified, fluoroscopic x-ray system that is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Dornier Nautilus is an Image Intensified Fluoroscopic X-ray System with a flat panel image receptor system. The Nautilus consists of the following components: an X- ray generator and tube housing, flat panel detector, monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics for the imaging chain. The Dornier Nautilus is a radiographic and fluoroscopy examination table with the X-ray tube housing mounted under the table on a fixed arm. A flat panel detector is mounted above the patient table. The flat panel used is a Varex model 4343DXV. These Varex 4343 series have been used in similar cleared devices (K192541). The Varex flat panel system uses Cesium lodide as the image scintillator which is identical to that used in the predicate device. While the X-ray tube and detector are fixed in their positions relative to each other when the system is in use, the table top and X-ray/detector unit can be moved in a variety of planes to position the patient in the desired imaging position. The captured images are processed and can be stored in the users DICOM system.

The Omega Medical Imaging, LLC Nyquist.IQ Image Processor is intended for use in Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging. The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP Systems.

Nyquist.IQ is a dynamic digital image processing system. The system application is based on a PC Windows operating system functioning on a PC based CPU. The object-oriented software performs real-time image processing and full procedure storage. The DICOM compliant connectivity provides the tools to transmit patient demographics, examination, and image data digitally. Nyquist.IQ is not a standalone device, but functions as a component for FDA cleared Omega CS-series-FP platform. Nyquist IQ is an image processor that interfaces, with to acquire and digitize x-ray exposure from the Omega medical CS-series-FP. The Nyquist.IQ operates in connection with the Varex's 3030 or the Teledyne 3030 flat panel detectors. This is demonstrated in the substantial equivalence section of the Nyquist.IQ is intended for the Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield platform. The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP systems. The Nyquist.IQ image processor. The fundamental performance characteristics of the Nyquist.IQ interventional fluoroscopic imaging Processor system consists of: - ) Real-time image visualization of patient anatomy during procedures - > Imaging techniques and tools to assist interventional procedures. - 2 Post-processing functions after interventional procedures. - 2 Storage of reference/control images for patient records. - Σ Compatibility to images of other modalities via DICOM - 2 Compatibility with the already FDA cleared CA-100S / FluoroShield AI Exposure Reduction Technology. (K182834) This array of functions provides the physician the imaging information required to achieve minimally invasive interventional procedures. The Nyquist.IQ image processor is available as a Model IPS-100 configuration and is similar to the currently marketed and predicate image processor MX-200 in CS-series-FP with optional CA-100S / FluoroShield Device.

ProxiDiagnost N90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography. The ProxiDiagnost N90 is a nearby controlled fluoroscopy system in combination with high-end digital radiography system consisting of a floor-mounted tilt adjustable patient support table and a scan unit consisting of a tube and a flat panel dynamic detector, Pixium FE4343F, for the fluoroscopy examinations. The tabletop can be moved by a motor in the lateral and longitudinal direction and can be tilted by -85° to +90° degrees. The scan unit tilts with the table and can be moved in the longitudinal and lateral direction, relative to the table and to the patient. The system is suitable for routine X-ray examinations and fluoroscopy examinations on patients in standing, seated or lying positions. The ProxiDiagnost N90 retrieves images by means of a Cesium Iodide flat panel detector. Philips fluoroscopy systems (standard configuration) consist of the Basic unit ("geometry" or "table unit"), Workstation Eleva Workspot (with integrated generator control, hand switch, keyboard, mouse, touch screen and PC), dual screen-monitor, Spot film device (digital camera or flat panel detector), Fixed Detector (Fluoroscopy), X-ray Generator for R/F applications, X-ray tube assembly. The optional components like wireless portable detectors small and large, Bucky tray for wireless portable detectors (SkyPlate) detector, Ceiling Suspension, Fixed Vertical stand, Ceiling Suspension for monitors, monitor trolley, Remote control for R/F (Radiography-fluoroscopy) viewer, accessories for “Stitching Stand", are also available. The Eleva software of the proposed ProxiDiagnost N90 is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Back-end (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images. The ProxiDiagnost N90 uses the same workflow from the currently marketed and predicate device, ProxiDiagnost N90 (K173433) with only the following modifications: - Inclusion of Extended reviewing options (like the optional reference monitor & remote control), - Inclusion of some image processing features - Updates to Operating system and Eleva application Software to include state-of-art operating system and incorporate the changes - Replacement of the ceiling suspension with that of reference device, DigitalDiagnost C90 (K202564) - Updates to improve serviceability - Option for upgradability of Predicate device (K173433) to include the above changes

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.