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The Philips 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 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 spectramay 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.

The Philips IQon Spectral CT 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 Philips IQon Spectral CT includes the detector array previously described in K131773 "Modified Brilliance iCT". The IQon Spectral CT 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. In addition to the above components and the software operating them, the system includes workstation hardware and software for data acquisition; and image display, manipulation, storage, and filming, as well as post-processing into views other than the original axial images. Patient supports (positioning aids) are used to position the patient.

The "Brilliance iCT" 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, components, and accessories.

The Brilliance iCT 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 Philips Ingenuity Digital PET/CT System is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical crosssections by computer reconstruction of x-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purpose of detecting, localizing, diagnosing, staging, re-staging and follow-up for monitoring therapy response of various diseases in oncology, cardiology and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools including application of the CT scanner for diagnosis and for use in radiation therapy planning.

The device is a hybrid diagnostic imaging system that combines Positron Emission tomography and X-ray computed tomography scanners that can be utilized in fixed installations. The device is comprised of the following system components/subsystems: Positron Emission Tomography (PET) scanner, X-ray Computed Tomography (CT) scanner, Patient Table

The IMR reconstruction feature is intended as an alternative to standard reconstruction methods (filtered back projection) for the reconstruction of CT scanner data to produce diagnostic images. The IMR reconstruction feature is designed to reduce image noise, increase high-contrast spatial resolution, and improve low contrast detectability. IMR is designed to reduce dose required for diagnostic CT imaging, Image quality improvements and dose reduction depend on the clinical task, patient size, anatomical location, and clinical practice. IMR images will be used by a trained medical professional for diagnosis of clinical conditions in patients, including pediatrics and adults, who have been prescribed a CT scan as part of their clinical care

The IMR reconstruction feature is intended as an alternative to standard reconstruction methods (filtered back projection) for the reconstruction of CT scanner data to produce diagnostic images. The IMR reconstruction feature is designed to reduce image noise, increase high-contrast spatial resolution, and improve low contrast detectability. IMR is designed to reduce dose required for diagnostic CT imaging. Image quality improvements and dose reduction depend on the clinical task, patient size, anatomical location, and clinical practice. The IMR Software Application will reside on any Philips CT System that meets minimum software platform and hardware requirements. IMR enables the user to apply iterative reconstruction techniques to reconstruct raw CT data to generate diagnostic CT images. The use of IMR to reconstruct images may be done prospectively or retrospectively.

The Philips Iterative Reconstruction Technique (IRT) Software Application is intended to reconstruct raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection reconstruction. Resulting IRT images are to be used to supplement conventional Filtered Back Projection images to aid the physician in diagnosis; they are not to be used as the sole basis for diagnosis.

The Philips IRT Software Application is a software option used for the reduction of noise in an image. IRT iteratively reconstructs raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection (FBP) reconstruction. This feature will be used by radiologists as a supplementary method to reconstruct CT raw data, in addition to traditional FBP.

The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Iniaging (MRI). The system does not expose the patient to ionizing radiation, only the dose contribution from the PET radiopharmaceutical. The MRI subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portions of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data. Image processing and display work stations provide software applications to process, analyze, display, quantify and interpret medical images/data via a single user interface. The PET and MRI images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professional use the images in: - The evaluation, detection and diagnosis of lesions, disease, and organ function . such as but not limited to cancer, cardiovascular disease, and neurological disorders. - . The detection, localization, and staging of tumors and diagnosing cancer patients. - Treatment planning and interventional radiology procedures. ♥ The device includes software that provides a quantified analysis of regional cerebral activity from the PET images. The MRI provides capabilities to perform interventional procedures in the head, body, and extremities which may be facilitated by MR techniques, such as real time imaging, such procedures must be performed with MRI compatible instrumentation as selected and evaluated by the clinical user.

The Ingenuity TF PET/MR system combines the Philips Achieva MR (K063559) and the Philips GEMINI PET/CT (Raptor, K052640) technologies. The system utilizes the MR technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of the both technologies is enhanced with the ability to fuse the MR and PET images using Philips fusion viewer software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for the quantification of results of the MR and PET images and provides a means for a simplified review of the fused images. Magnetic Resonance Imaging is a medical imaging technique that is based on the principle that certain atomic nuclei present in the human body emit a weak relaxation signal when placed in a strong magnetic field and excited by a radio signal at the precession frequency. The emitted relaxation signals are analyzed by the system and a computed image reconstruction is displayed on a video screen. Positron Emission Tomography uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high resolution, three dimensional images of biochemical and metabolic processes of organs within the body. The Ingenuity TF PET/MR system consists of two gantries integrating the MR scanner and the PET scanner, a patient table to support the patient, within the gantries, and a scanning console and viewing console at the operator's workstation.