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The KODEX-EPD™ System 1.5.0 is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD ™ System 1.5.0 provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure.

The KODEX-EPD™ System 1.5.0 is a catheter-based cardiac mapping system designed to acquire and analyze individual data points, and use this information to display 3D electro-anatomical maps of the human heart in real-time. The information needed to create the cardiac maps is acquired using standard electrophysiological (EP) catheters and proprietary external sensors. KODEX - EPD™ continuously collects electromagnetic signals from all sensors and electrodes attached to it. The system then uses these to create a 3D image of the chamber, and superimposes the real time catheter position on the chamber image. In addition, the KODEX – EPD™ System 1.5.0 supports representation of the electrical activity of cardiac chambers, based on the intra cardiac signals received from the all catheters and body surface signals.

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, 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 proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 are provided on the 60 cm and 70 cm bore 3.0 Tesla (3.0T) Magnetic Resonance Diagnostic Devices. This bundled abbreviated 510(k) submission will include modifications of the 3.0T systems, included in the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 (K193215, 04/10/2020). This 510(k) submission will address the following HW and SW modifications for the proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 since the clearance of the last submission for each of the systems: New system MR 7700 which contains modified gradient system compared to Ingenia Elition X Modified Multi Nuclei option, now available for all 3.0T systems This 510(k) submission will also address minor hardware and software enhancements: Universal Mains Distribution Unit (uMDU) 3.0T 1H RF Amplifier Extended Functionality Options The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA: mDIXON (K102344) SWIp (K131241) mDIXON-Quant (K133526) mDIXON XD (K143128) O-MAR K143253 3D APT (K172920) Coils compatible with Ingenia 3.0T, Ingenia 3,0T CX, Ingenia Elition and MR 7700 The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 are substantially equivalent to the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 (K193215, 04/10/2020).

The Precise Image is a reconstruction software application for 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 supports, components and accessories. Precise Image has been evaluated and available on preselected reference protocols for adult subjects. Precise Image is not indicated for use in pediatric subjects. The CT system with Precise Image is indicated for head, whole body and vascular X-ray Computed Tomography applications. These scanners are intended to be used for diagnostic imaging. Precise Image uses an Artificial Intelligence powered reconstruction that is designed for low radiation dose, provides lower noise, and improves low contrast detectability.

The proposed Precise Image is a reconstruction software application that may be used on a Philips whole-body computed tomography (CT) X-Ray System. Precise Image is a robust reconstruction software application, utilizing technological advancements in Artificial Intelligence and a Convolutional Neural Networks (CNN), When used, Precise Image generates CT images that provides an image appearance similar to traditional FBP images while reducing dose and improving image quality. The implemented algorithm includes 5 user-adjustable settings to match the Radiologist's preference for dose reduction and image quality. The proposed Precise Image reconstruction has been trained on and may be used on the currently marketed predicate device Philips Incisive CT System (K180015).