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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 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 90 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).

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 proposed MR 5300 and MR 7700 R11 MR Systems are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices, hereafter to be known as MR 5300 and MR 7700 MR Systems. This Special 510(k) submission will include modifications of the proposed MR 5300 and MR 7700 R11 MR Systems as compared to our legally marketed devices, primary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 05/16/2022) and the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021). The proposed MR 5300 and MR 7700 MR systems will be brought up to the new baseline software R11. This R11 software is cleared on the Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems in the following primary predicate 510(k) Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022). Both the proposed MR 5300 and MR 7700 MR systems are already cleared with the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021).

ClarifEye is intended to be an intra-operative image-guidance tool used during surgical and interventional therapy. It provides assistance to the performing physician to align a device with a virtual path that is planned on a 3D volume of the anatomy. This alignment is provided in the following ways: -The virtual path is superimposed with a live video image of the area of interest. -The position of the ClarifEye Needle is superimposed with the video images of the area of interest and/or the 3D images of the anatomy. ClarifEye is intended to be used on patients who have been elected for procedures where a straight, rigid device is placed in the spine, such as sacral, lumbar and thoracic pedicle screw placement. ClarifEye is indicated for procedures where a reference to bony anatomical structures can be established using skin markers as a reference. The ClarifEye Needle is a manual, surgical instrument intended to be used during spine surgery to facilitate placement of guidewires. The needle may be used as part of a planning and intraoperative guidance system (i.e. Philips intra-operative image guidance tool) to enable open or percutaneous image guided therapy. The ClarifEye Needle is indicated for use during posterior pedicle screw procedures, such as in the sacral, lumbar and thoracic spinal regions, in which the use of image guided surgery may be appropriate. The ClarifEye Needle is EtO sterilized, for single use only and have to be disposed after use, according to local waste disposal methods for potentially bio hazardous material.

ClarifEye is a software medical device that is intended to be an intra-operative image-guidance tool used during surgical and interventional therapy. It will be offered as an optional accessory to the Philips interventional fluoroscopic X-ray system, from which it receives 2D X-ray and video images. ClarifEye implements an automatic reconstruction (algorithm) to create 3D CBCT images from a rotational scan acquired on the X-ray system. Clarif Eye integrates the live video images of the surgical view and live 2D X-rav image which it overlays on the planned path shown in the reconstructed 3D CBCT image to provide navigational assistance, in real-time. ClarifEye provides assistance to the performing physician to align a device, such as a needle with a virtual path that is planned on a 3D image of the anatomy. The created 3D planning can be overlaid on live video images ("Augmented View") or live 2D fluoroscopy images, to monitor device deployment during the procedure. ClarifEye is intended to be used in combination with the compatible ClarifEye Needle and ClarifEye Markers. The ClarifEye Needle is for optional use only, when needle tip tracking is desired.

The Philips Hemodynamic Application is intended for use by professional healthcare providers for physiologic/ hemodynamic monitoring, medical data processing and analytical assessment. The software may be used to display analyze surface Electrocardiogram (ECG), Respiration. Invasive Blood Pressure (IBP), Pulse Oximetry (SpO2), End Tidal CO2 (ETCO2), Fractional Flow Reserve (FFR), Instant Wave-Free Ratio (iFR), Non-Invasive Blood Pressure (NIBP), surface body Temperature and thermal Cardiac Output. The software is intended for use with other devices, such as physiological monitoring systems, information management systems, image acquisition and other medical devices. Use of the software in combination with physiological monitoring system is not intended to be used where unattended patient monitoring is desired, or in situations where arrhythmia detection is required. The software in combination with an information management system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet. The software is indicated for use in the following areas; (interventional) cardiology, electrophysiology, The Philips Hemodynamic Application is indicated for use for all human patients of all ages.

Philips Hemodynamic Application is a new software medical device that enables invasive investigation of cardiac and vascular disease. It will be offered as an optional accessory to the Xper Flex Cardio Physiomonitoring System, (K101571). Currently, the functionality offered by the Philips Hemodynamic Application is provided by "Hemodynamic Control Software" of the currently marketed and predicate Xper Flex Cardio Physiomonitoring System. The software connects to the patient monitor (i.e. the Xper Flex Cardio Physiomonitoring System) and during the intervention continuously acquires realtime physiological data and alarms. In addition, Philips Hemodynamic Application provides the following functionality: - Visualize and analyze: surface ECG, Respiration rate (RR), Invasive . Blood Pressure (IBP), Pulse Oximetry (SpO2), End Tidal CO2 (etCO2), Noninvasive monitoring and recording of Non-Invasive Blood Pressure (NIBP), Body surface temperature (Tskin); - Provide Hemodynamic calculations: Fractional Flow Reserve (FFR), Instant Wave-Free Ratio (iFR), thermal cardiac output parameters, valve area and valve gradient. Furthermore, Philips Hemodynamic Application also interfaces with Xper Information Management (XperIM) System (K101571) which it can transfer data to for the purpose of data collection/display, processing and patient reporting.

SmartPerfusion assists in the diagnosis of perfusion of tissues based on digital subtraction angiography (DSA) and can be used for any location in the body where DSA is used.

SmartPerfusion is a software product (Interventional Tool) that provides color coded representation of a digital subtraction angiography (DSA). It can visualize multiple functional parameters related to the time density function. It also provides a comparison between pre-, peri-, and post- procedural color coded images. SmartPerfusion is provided as an accessory to the Philips Interventional X-ray system.

Philips IntelliSpace Portal Platform is a software medical device that allows multiple users clinical applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. This software is for use with off-the-shelf PC computer technology that meets defined minimum specifications . Philips IntelliSpace Portal Platform is intended to be used by trained professionals, including but not limited to physicians and medical technicians. This medical device is not to be used for mammography. The device is not intended for diagnosis of lossy compressed images.

Philips IntelliSpace Portal Platform is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. This software is for use with offthe-shelf PC computer technology that meets defined minimum specifications. The IntelliSpace Portal Platform communicates with imaging systems of different modalities using the DICOM-3 standard.

mDIXON XD is a software option intended for use on Achieva, Ingenia 1.5T & 3T MR Systems. It is indicated for use in Magnetic Resonance Imaging of the human body. mDIXON XD is an enhanced 2-point fat-free mDIXON technology, available for gradient echo and spin echo acquisitions. mDIXON XD enables the combination of a fat-free technology with the MultiVane XD motion-free technique for anatomies such as head. mDIXON XD also enables subtractionless MR Angiography in areas of the body where exogenous contrast media has been approved for MR imaging.

mDIXON XD provides an improved water/fat reconstruction algorithm (7-peak fat modeling, B0correction and fat-shift correction). mDIXON XD relies on the 2-point mDIXON fat-free technology making use of unrestricted echo times and is capable of generating four image contrasts (Water, Fat, In-Phase, Out-Phase) in one scan. mDIXON XD can be used with the following: - Multivane XD (motion correction) for the head - MR Angiography (subtractionless MRA), removes the need for the subtraction of the pre-● and post-contrast enhanced images. - Gradient echo (FFE Fast Field Echo) and turbo spin echo (TSE) sequences to achieve ● efficient fat-free scanning compatibility, even at large FOV or sub-millimetric resolutions mDIXON XD is supported on the following systems: - 3.0T Ingenia - 3.0T Achieva ● - 1.5T Ingenia - 1.5T Achieva ● The functionality is supported on all available gradient performance levels. Optimized protocols will be provided for the different performance points. mDIXON XD is supported on the centralized data acquisition systems of the Achieva systems as well as the digitally networked data acquisition system of the Ingenia systems. The data acquisition system is fully transparent to the pulse sequences and mDIXON XD reconstructions.