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The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. The device is to be used in health care facilities both inside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications: - Orthopedic - Neuro - Abdominal - Vascular - Thoracic - Cardiac

The proposed Zenition 30 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed. The system comprises of two main components: the C-arm stand and a Mobile View Station (MVS).

The proposed Zenition 70 is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications: - Orthopedic - Neuro - Abdominal - Vascular - Thoracic - Cardiac

The proposed Zenition 70 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed. The system comprises two main components: The C-arm stand and a mobile view station.

The Azurion series (within the limits of the Operation Room table) are intended for use to perform · Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. · Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: - · The Azurion series can be used in a hybrid Operation Room · The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

The Azurion R2.1 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Azurion R2.1 interventional fluoroscopic X-ray system include: 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 This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures. The Azurion R2.1 is available in comparable models and configurations as the currently marketed and predicate device Azurion R1.2. Configurations are composed of detector type (monoplane and biplane), floor or ceiling mounted geometry, standard or OR table type and available image processing. The FlexArm option is available for the 7M20 configuration in Azurion R2.1 The monoplane (single C-arm) and biplane (dual arm) X-ray system configurations are differentiated by the following features: 12 inch Flat Detector (FD12) 15 inch Flat Detector (FD15) 20 inch Flat Detector (FD20) Additionally, identical to the predicate device, Azurion R2.1 can be used in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.

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 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 Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 with MultiBand SENSE software feature are provided on the 60 cm and 70 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) Magnetic Resonance Diagnostic Devices. Hereafter Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 with MultiBand SENSE software feature will be referred to as the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems in this submission. This bundled abbreviated 510(k) submission will include software modifications to the following legally marketed MR systems: Ingenia 1.5T, Ingenia 1.5T S, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S and Ingenia Ambition X (K183063, 02/14/2019) and Achieva 1.5T, Achieva 3.0T, Intera 1.5T (K190461, 06/04/2019). All of the aforementioned legally marketed systems will be brought up to the new baseline software R5.7. This submission addresses only software modifications, there are no hardware modifications made to any of the above legally marketed systems. In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing modifications to MultiBand SENSE and one labeling change to the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems: • Removal of contra-indication statement of Compressed SENSE with Gd contrast agent This 510(k) submission will also address minor software enhancements contained in software R5.7 for the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems since the clearance of the last submission for each of the systems: 1. 4D FreeBreathing 2. MR Elastography Extension 3. EPIC Brain 4. LOVA ADC 5. Computed DWI 6. SmartShim 7. VitalScreen 8. Extended Functionality Options The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA: 1. mDIXON (K102344) 2. SWIp (K131241) 3. mDIXON-Quant (K133526) 4. mDIXON XD (K143128) 5. O-MAR K143253 6. 3D APT (K172920) 7. Ingenia Coils The proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems are substantially equivalent to the legally marketed predicate device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063, 02/14/2019). In addition, the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems is substantially equivalent to the following legally marketed reference devices: MultiBand SENSE software application (K162940, 12/30/2016), to support MultiBand SENSE for 1.5T and to support diffusion body imaging on 1.5T and 3.0T.Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T CX, and Ingenia 3.0T CX R5.4 K173079, 04/04/2018, to support the removal of the contra-indication of the compatibility of Compressed SENSE with (dynamic) Gadolinium contrast-enhanced imaging.

The Zenition 50 device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications: Orthopedic Neuro Abdominal Vascular Thoracic Cardiac

The proposed Zenition 50 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed. The system comprises of two main components: the C-arm stand and a Mobile View Station(MVS)

The Zenition 70 device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device is to be used in health care facilities both inside and outside the operating room, sterile environment in a variety of procedures. Applications: - Orthopedic . - · Neuro - · Abdominal - . Vascular - · Thoracic - · Cardiac

The proposed Zenition 70 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed. The system comprises two main components: the C-arm stand and a mobile view station

The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: - Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. - Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: - The Azurion series can be used in a hybrid Operation Room. - The Azurion series contains a number of features to support a flexible and patient centric procedural workflow.

The Azurion R2.0 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Azurion R2.0 interventional fluoroscopic X-ray system include: - 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 This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures. The Azurion R2.0 is available as a single monoplane (single C-arm) configuration of the currently marketed and predicate devices Azurion series R1.2 consisting of a FD20 (frontal channel) detector with a ceiling (Clea) geometry having a standard or OR compatible table. This can optionally be configured with a horizontal L-arm which provides an extra rotation axis, with re-designed motion control software providing patient and X-ray beam positioning movement and an improved 3D roll scan time. Additionally, identical to the predicate devices, Azurion R2.0 can be used in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.

The Interventional Workspot has the following medical purpose: · import, export and storage of digital clinical images, · manage the patient information associated with those images.

The Interventional Workspot is a software platform to host Interventional Tools. It provides common functionalities (e.g. import / export and data handling functions) that are required by the Interventional Tools to support the physician with performing the interventional procedure.

The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: · Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures, · Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: - · The Azurion series can be used in a hybrid Operation Room. · The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

The Azurion series R1.2 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Azurion series R1.2 interventional fluoroscopic X-ray system include: - Real-time image visualization of patient anatomy during procedures ● - Imaging techniques and tools to assist interventional procedures ● - Post processing functions after interventional procedures o - Storage of reference/control images for patient records ● - Compatibility to images of other modalities via DICOM o - Built in radiation safety controls ● This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures. The Azurion series R1.2 is available in a comparable set of configurations for monoplane models as the currently marketed and predicate devices Allura Xper R9. Configurations are composed of detector type. (monoplane) geometry, table type and available image processing. The monoplane (single C-arm) and biplane (dual arm) systems are categorized into X-ray systems and the configurations are differentiated by the following features: - 12 inch Flat detector (FD12) - 15 inch Flat detector (FD15) - 20 inch Flat detector (FD20) ● Additionally, identical to the predicate devices, all configurations of the Azurion series R1.2 can be used in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.

Dynamic Coronary Roadmap is intended to assist the physician during percutaneous coronary interventions in correlating the device position to the coronary vasculature, by providing a motion compensated overlay of this coronary vasculature. Dynamic Coronary Roadmap is suitable for use with the entire adult human population. Dynamic Coronary Roadmap is a software medical device and does not come in contact with a human subject.

The Dynamic Coronary Roadmap is a software medical device intended to provide a real-time and dynamic angiographic roadmap of coronary arteries. The angiographic roadmap is automatically generated from previously acquired diagnostic coronary angiograms during the same procedure. Dynamic Coronary Roadmap uses coronary angiograms, acquired during a PCI procedure, to automatically generate a dynamic angiographic roadmap of the coronary vasculature. This roadmap is then overlaid on the live fluoroscopy images during device navigation. Dynamic Coronary Roadmap works in combination with a Philips interventional X-ray system. The user interface of Dynamic Coronary Roadmap guides the physician through the workflow and minimal additional user interaction from the tableside is required. The following design features support the physician with this: - Dynamic angiographic roadmap creation; this technique allows the physician to automatically construct a 2D dynamic angiographic roadmap of the coronary vasculature from a diagnostic coronary angiogram. - Live guidance; this technique provides continuous overlay of the dynamic angiographic roadmap on live fluoroscopic images. - X-ray system integration; this provides the physician with a seamless integration with the Philips interventional X-ray system. The clinical product supports: - Automatic power ON or OFF; this allows the software medical device to always be available by automatically powering ON and OFF with the X-ray system. - 3D Automatic Position Control (APC); this allows the C-arm to automatically move to a nearby available dynamic angiographic roadmap to be able to reuse this for live guidance. - Table-side control; this provides the physician with an efficient workflow during interventional procedures. The most frequently used functions that require additional user interaction next to the normal x-ray system interaction can be controlled from the tableside of the Xray system.