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The Philips iCT CT systems is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. The iCT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The Philips iCT CT System is a whole-body computed tomography (CT) X-ray system designed for diagnostic imaging. It features a continuously rotating X-ray tube and multi-slice detector gantry, enabling the acquisition of X-ray transmission data from multiple angles and planes. The system reconstructs these data into cross-sectional images using advanced image reconstruction algorithms, supporting a wide range of clinical applications. The system consists of a gantry, which houses the rotating X-ray tube, detector array, and key imaging subsystems; a patient support couch, which moves the patient through the gantry bore in synchronization with the scan and is available in multiple configurations; an operator console, which serves as the primary user interface for system controls, image processing, and data management; and a Data Measurement System (DMS), which captures X-ray attenuation data to support high-quality image reconstruction.

Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast agents. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent. The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters and must be controlled and validated by the clinical user. In addition, the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.

The subject Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR Systems are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices. A new optional software feature SmartSpeed Precise is contained in software R12.3 for the subject Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR Systems. SmartSpeed Precise is a machine learning based reconstruction technique designed to increase the signal-to-noise (SNR), increase the sharpness, and reduce residual ringing artifacts in MR images. The introduction of SmartSpeed Precise only required updates to the MR System Software. The subject Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR Systems are intended to be marketed with the same pulse sequences and coils that are previously cleared by FDA: The accessories to be used with the subject Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR Systems have not changed compared to the predicate device and can be found in the Instructions for Use accompanying the device. When Philips MRI system is used in combination with the Philips MR-RT or MR-OR solutions, the user is referred to the dedicated MR-RT and MR-OR Instructions for Use for information on additional accessories that may apply.

The Spectral CT system is a Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment support, component parts, and accessories. The Spectral CT system acquires one CT dataset – composed of data from a higher-energy detected X-ray spectrum and a lower- energy detected X-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology as part of treatment preparation and radiation therapy planning. The Extended field of view images and respiratory correlated scanning (4DCT) are for treatment preparation and radiation therapy planning/simulation usage only. This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl. J Med 2011; 365:395-409) and subsequent literature, for further information.

Spectral CT system is a whole-body computed tomography (CT) X-ray system featuring a continuously rotating X-ray tube and detectors gantry, and multi slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This system also includes signals analysis and display equipment, patient and equipment support, components, and accessories. The Spectral CT system acquires one CT dataset – composed of data from a higher energy detected X-ray spectrum and a lower- energy detected X-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and provides information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. The Spectral CT system consists of three main components – a scanner system that includes a rotating gantry, a movable patient couch, and an operator console for control and image reconstruction; a Spectral Reconstruction System; and a Spectral CT Viewer. On the gantry, the main active components are the X-ray high voltage (HV) power supply, the X-ray tube, and the detection system. The fundamental design and characteristics of the main components used in the proposed Spectral CT system are identical to the currently marketed primary predicate device, Spectral CT system (K203020).

VitalSigns Camera Medical Library is a software library that can be integrated into a customer application for use during virtual consults or health screening. It is intended for spot checking of Respiration Rate (RR) in an automatic contactless manner as a data point in the overall assessment of the patient. It is used under the supervision of a health care professional, either in the home or in a clinical environment when the subject is still and positioned properly in front of the camera (Samsung Galaxy A20e), which is placed on a stable surface in an adequately lit environment. It is intended to be used on patients aged 22 years and older that classify as ASA I (American Society of Anesthesiologists), which is defined as a normal healthy patient, non-smoking and no or minimal alcohol use. It is not intended for continuous patient monitoring system or as the sole method of checking the physical health of the patient, nor as an apnea monitor, but as a part of a framework which mandates periodic checks by a health care professional to ensure appropriate clinical diagnosis and treatment can be reached.

The Philips VitalSigns Camera Medical Library (hereafter known as Philips VSC-MEDlib) is a software library that shall be used in conjunction with a camera which can be part of another platform or as part of a medical device. The Philips VSC-MEDlib incorporates an algorithm which allow for automatic, contactless measuring of Respiration Rate (RR). Philips VSC-MEDlib utilizes the video stream of an unobstructed view of the subject's torso captured from a camera to calculate the RR from torso motion. The video stream can be captured during a video consult or health screening which should always be conducted in the presence of a physician or other Health Care Professional (HCP). The patient must be properly positioned in front of the camera, sitting still and in an adequately lit environment. From a video stream that typically lasts 60 seconds or less, a spot measurement is taken.

The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. The PIPS 5.1 is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS 5.1 is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The PIPS 5.1 comprises the Imagement System (IMS) 4.2, Ultra Fast Scanner (UFS), Pathology Scanner SG20. Pathology Scanner SG60, Pathology Scanner SG300 and Philips PP27QHD display, a Beacon C411W display or a Barco MDCC-4430 display. The PIPS 5.1 is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS 5.1.

The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. PIPS 5.1 consists of two subsystems and a display component: - 1. A scanner in any combination of the following scanner models - . Ultra Fast Scanner (UFS) - Pathology Scanner SG with different versions for varying slide capacity . Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300 - 2. Image Management System (IMS) 4.2 - 3. Clinical display - PP27QHD or C411W or MDCC-4430 . PIPS 5.1 is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. The PIPS does not include any automated image analysis applications that would constitute computer aided detection or diagnosis. The pathologists only view the scanned images and utilize the image review manipulation software in the PIPS 5.1.

The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. The PIPS 5.1 is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS 5.1 is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The PIPS 5.1 comprises the Imagement System (IMS) 4.2, Ultra-Fast Scanner (UFS), Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300 and Philips PP270HD display or a Beacon C411W display. The PIPS 5.1 is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS 5.1.

The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. PIPS 5.1 consists of two subsystems and a display component: - 1. A scanner in any combination of the following scanner models - . Ultra Fast Scanner (UFS) - . Pathology Scanner SG with different versions for varying slide capacity Pathology Scanner SG20. Pathology Scanner SG60. Pathology Scanner SG300 - 2. Image Management System (IMS) 4.2 - 3. Clinical display - PP27QHD or C411W PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. The PIPS does not include any automated image analysis applications that would constitute computer aided detection or diagnosis. The pathologists only view the scanned images and utilize the image review manipulation software in the PIPS.

The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing and management, system. The PIPS is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The PIPS comprises the Image Management System (IMS) the Ultra Fast Scanner (UFS) and Philips PP27QHD display or a Beacon C411W display. The PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the interpretation of images obtained using PIPS.

The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing and management, system. The PIPS comprises the Image Management System (IMS) the Ultra Fast Scanner (UFS) and Philips PP27QHD display or a Beacon C411W display.

ROCC Console is intended for remote scanning, support, review, monitoring and standardization of imaging protocols of medical imaging devices. It is a multi-vendor solution allowing view-only or full access control to connected devices. ROCC Console is also intended for training of medical personnel working on connected medical imaging devices.

ROCC Console is a software device, which is part of the ROCC (Radiology Operations Command Center) system, a cloud-based solution which can connect expert radiology users located at a remote command center with onsite technologists operating an MR/CT scanner on-demand, while enabling real-time operational support/guidance for the scanner console. This ROCC system allows healthcare professionals to share expertise, even when they are not physically present in the same location. Expert users are working from remote office locations within a healthcare facility or from a home office. ROCC Console is a multiple function device product. The medical device functions include the ability to console of a connected MR/CT scanner from a remote location, and a Protocol Management mode, which can be used to manage updates / harmonize scan protocols across connected MR/CT scanners. ROCC Console is vendor neutral. It is intended to be used in healthcare environments including imaging modalities (MR or CT) with digital output (DP, DVI, and HDMI) which are either fixed to one location or are in mobile (truck) environments where medical imaging services are provided. ROCC Console supports three connection methods to exchange the KVM (Keyboard, Video and Mouse) information between the expert user and the technologist. The proprietary software KVM connection includes two applications: a "Console Transmitter App" for use by the technologist on the scanner side, and a "Console Receiver App" for use by the remotely located expert user. The Console Transmitter App is a native Windows application installed on a desktop system, which sends the console video stream over the internet to the Console Receiver App. The Console Receiver App is a web-application that can run on a web browser, and receives and displays the video stream to the remotely located expert user edits the scanner console through mouse and keyboard entries, it sends these keyboard and mouse entries back to the Console Transmitter App, which subsequently sends the scanner console. Additionally, ROCC Console supports off-the-shelf HW/SW KVM switch or VNC. ROCC Console can be used with 3 MR/CT console connections concurrently. When a patient is to be scanned, the on-site technologist must remain present at all times and retains full control over the MR/CT scanner console and can terminate the editing authorization at any time. For CT connections, full access is limited to what is available in the software associated with the modality workspace and is not applicable to physical switches controlling the radiation exposure. The Protocol Management mode allows access to the MR/CT scanner console without a technologist on site. It is only intended for protocol management and harmonization and not for any remote imaging support.