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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 MR scan technique applied, and presence of contrast agents. The use of contrast 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, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assust 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.

This Special 510(k) submission will include modifications of the proposed Ingenia Elition and MR 7700 MR Systems as compared to Philips legally marketed devices, primary predicate device MR 7700 R11 MR System of the 510(k) submission MR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) as well as the secondary predicate device being the legally marketed Ingenia Elition R11 MR System of the 510(k) submission Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022). In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing the following minor hardware enhancements for the proposed Ingenia Elition and MR 7700 MR Systems since the last 510(k) submission (K223442, 12/23/2022) for each of the systems: 1. The SmokeDetector Interlock, a component used in the legally marketed Ingenia Elition and MR 7700 systems, becomes a mandatory risk control measure. 2. Minor design change to current gradient coil type WB30S Identical to the predicate devices, the proposed Ingenia Elition and MR 7700 MR Systems are intended to be marketed with the following pulse sequences and coils that are previously cleared by FDA: 1. mDIXON (K102344) 2. SWIp (K131241) 3. mDIXON-Quant (K133526) 4. MRE (K140666) 5. mDIXON XD (K143128) 6. O-MAR (K143253) 7. 3D APT (K172920) 8. Compatible System Coils (identical to the predicate devices)

SmartCT assists physicians during vascular and non-vascular procedures, with diagnosis, treatment planning, interventional procedures and treatment follow-up by creating 3D views from sets of 2D images created during rotational acquisitions. SmartCT provides high-speed and high-resolution 3D visualizations of vasculature, hemorrhages, soft tissue and bone structures. SmartCT provides live image guidance for navigating endovascular structures anywhere in the body. SmartCT helps to assess anatomical intra-procedurally, such as the estimate of a vessel or lesion size, diameter or volume, and anatomical distances between relevant structures. SmartCT is intended to be used for human patients that have been elected for the procedures as described in the Indications for Use.

SmartCT is a 3D image visualization and analysis software product (Interventional Tool) intended to provide fast and high-resolution 3D visualization of vasculature, hemorrhages, soft tissue and bone structures, thereby helping the physician to identify pathologies and supporting the physician to define and plan the intervention strategy. SmartCT runs on a software platform called the Interventional Workspot, and is intended to be used with a Philips Interventional X-Ray System. SmartCT supports 3D Rotational Angiography (3DRA), Cone Beam CT (CBCT) and VasoCT acquisition protocols, and it includes 3D roadmap functionality. The CBCT and VasoCT protocols are only available for the 20" detector of the Interventional X-Ray system. The 3DRA protocols are available for all detectors. The 3DRA protocols are available with SmartCT Angio, the CBCT protocols with SmartCT Soft Tissue and the VasoCT protocols with SmartCT Vaso. The 3D roadmap functionality (SmartCT Roadmap) comes in combination with SmartCT Angio, SmartCT Soft Tissue or SmartCT Vaso. SmartCT includes filters to improve the image quality of the reconstruction by reducing the noise caused by metal objects or other objects that absorb high levels of X-ray radiation. SmartCT provides overlays of live 2D fluoroscopic images with a 3D reconstruction of the vessel tree. SmartCT offers tools to manually measure sizes and volumes of anatomical structures such as lesions, aneurysms or vessels. It also offers a vessel analysis tool that provides semi-automatic measurements of the diameter of a segmented vessel. SmartCT can be controlled from both the control room and the examination room. SmartCT provides workflow guidance to support the physician in the workflow of acquiring and processing 3D images.

The IQon Spectral CT 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 supports, component parts, and accessories. The IQon 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 spectra may be used to analyse 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 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 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 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.

The proposed IQon 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 device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories. The proposed IQon Spectral CT System includes the detector array, which is identical to the currently marketed and predicate device – Philips IQon Spectral CT System (K163711). The proposed IQon Spectral CT System consists of three main components, that are identical to the currently marketed and predicate device. Philips IQon Spectral CT System (K163711) - 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. In addition to the above components and the software operating them, the proposed IQon Spectral CT System includes workstation hardware and software for data acquisition; image display, manipulation, storage, and filming, as well as post-processing for views other than the original axial images. Patient supports (positioning aids) are used to position the patient.

O-MAR is a combination of an acquisition technique and post-processing software intended for use on Achieva and Ingenia, 1.5T & 3T MR Systems. O-MAR is suitable for use on all patients with passive MR Conditional orthopedics implants that are scanned according to the conditions of safe use for the specific MR Conditional implant being scanned. In addition O-MAR is suitable for use on patients without implants that are cleared for MR exams. O-MAR helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus O-MAR improves visualization of more tissue in the vicinity of MR Conditional orthopedic implants. When interpreted by a trained physician, images generated by O-MAR provide information that can be useful in determining a diagnosis.

The O-MAR feature has two components. The SEMAC+VAT feature and the MARS+VAT feature. SEMAC+VAT is a Turbo Spin Echo method in combination with VAT (View Angle Tilting) and with multiple z-encodings per excited slice (aka SEMAC) to reduce in-plane and through-plane distortions caused by magnetic field inhomogeneities. MARS is high band width TSE. MARS+VAT can also be referred to as high band width TSE+VAT. A difference between SEMAC+VAT and MARS+VAT is that SEMAC+VAT also provides through plane as well as in plane artifact reduction, MARS+VAT only provides in plane artifact reduction. SEMAC uses a slice selective TSE acquisition. Multiple z-encodings per excited slice are used to recover off-resonant signal caused by magnetic field inhomogeneities. The output image for each slice represents a combination of the signal acquired at different off-resonant frequencies. SEMAC takes care of corrections in the through-slice direction. The VAT (View angle tilting) technique is used to reduce in-plane distortions. For this, the gradient applied during slice selection is reapplied during the signal readout. The feature consists of: - Specific imaging sequence based on multiple overlapping 3D volumes, where the 3D volume aims at capturing the different frequencies caused by the distortion. - A new calculation function to combine different frequency MR signals into a single . undistorted slice. - A TSE-based SENSE reference scan, which is more robust towards the metal distortions than standard FFE reference scans - VAT gradient control in sequences. - . VAT is combined with SEMAC or MARS. MARS (Metal artifact reduction sequence) is a slice selective high bandwidth TSE sequence which can be achieved with standard settings of the TSE sequences.