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The Radiography 7000 M is intended for diagnostic procedures on both adult and pediatric patients who are unable to be transferred to the stationary X-ray system. It enables radiographic imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions. The system allows for applications in different positions, such as sitting, standing, and lying in either a prone or supine position. However, it should be noted that the system is not suitable for mammography applications.

The Radiography 7000 M digital mobile will be a new motorized mobile x-ray system that will employ integrated wireless flat panel detectors of two different sizes (large and small) to obtain digital images in mobile environments; the system will also be able to utilize CR or traditional film cassettes in a back-up scenario. The system will primarily use wireless technology for image acquisition and the transmission of images to archive systems like PACS, as well as for the retrieval of patient and exam information from the radiology information system (RIS) or hospital information system (HIS). The system is available in the following configurations: with 20 kW X-ray generator, with 40 kW X-ray generator. The Radiography 7000 M system is an integrated system consisting of the following subsystems: Base Unit (Sedecal Mobile X-ray system SM-IV, cleared under K232185 August 21, 2023), SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories, Eleva WorkSpot 43.0.

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.

Philips Radiology Smart Assistant is intended to provide patient positioning feedback using validated 2D X-Ray systems. Philips Radiology Smart Assistant is a software which informs Healthcare Professionals regarding patient positioning quality in accordance with clinical guidelines. Philips Radiology Smart Assistant is not intended for diagnostic purposes. It is not intended to be used as the basis for repeating an image.

Philips Radiology Smart Assistant is a software package intended to be used by qualified healthcare professionals. The software is used with general purpose computing hardware for the processing, display of images, and patient positioning feedback within a clinical environment. Philips Radiology Smart Assistant software supports receiving and displaying images from X-ray systems. The system supports receiving, sending, storing, acceptance and displaying of medical images received from the following modality types via DICOM: DX as well as hospital/radiology information systems. Philips Radiology Smart Assistant includes a post-processing patient positioning feedback function for posterior-anterior (PA) chest X-ray images. The patient positioning assessment is intended to provide a qualified healthcare professional with timely feedback on the quality of acquired X-ray images that do not suffice the positioning quality standards of clinical guidelines. The quality check comprises an assessment of the following parameters: - Collimation - Patient Rotation - Patient Inhalation State

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 DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.

The proposed DigitalDiagnost is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The system is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE. Together with the tube these components form the radiography Image Chain. The additional option of the portable wireless detector i.e. the SkyPlates family can be used for free exposures as well as in the patient support table or in the vertical stand. The proposed DigitalDiagnost is a modification of the predicate device, DigitalDiagnost C90 (K202564). The modifications include change of colour of the table, stand and ceiling suspension; changes in ceiling suspension, service features and a software update. The changes related to the software updates and service features have been recently cleared in the reference device, CombiDiagnost R90 (K203087).

CombiDiagnost R90 is a multi-functional general RF 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 lying positions. The CombiDiagnost R90 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), Dynamic detector, Fixed detector, X-ray Generator Velara, X-ray tube assembly, Receptor (Flat panel detector). The optional component like 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", are also available. 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. As part of the radiographic system, the Eleva software is intended to acquire, process, store, display and export digital Fluoroscopy and radiographic 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 Front-end Software is intended to acquire images. - The Back-end Software is intended to query patient data from Radiology Information System (RIS), store, display and export digital radiographic images to Picture Archiving and Communication System (PACS) - The Image Processing Software is intended to perform the pre and post processing on the acquired raw images. 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 (K202564) along with functional clusters like Digital Subtraction Imaging and stitching on the table - updates to improve usability and serviceability. -

The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.

The proposed DigitalDiagnost C90 is same as the 510(K) approved predicate (K182973) as mentioned below. It is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The proposed DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE, together with the tube these components form the radiography Image Chain. The proposed DigitalDiagnost C90 introduces a new wireless portable detector, pixium 3543DR i.e. SkyPlate E (cleared in reference device 510(K) K191813) and their relevant grids, in addition to the family of SkyPlate detectors (pixium 3543EZ i.e. Large and pixium 2430EZ i.e. Small) that are already integrated in the currently marketed (predicate) DigitalDiagnost C90 (K182973).

The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.

The DigitalDiagnost C90 is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE (K170113 - February 9, 2017), together with the tube these components form the radiography Image Chain. As additional options, a portable detector (K141736 - July 25, 2014) can be used for free exposures as well as in the patient support table or in the vertical stand.