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This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities. Magnetic Resonance images represent 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. The image acquisition process can be synchronized 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 the 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. For some studies the use of contrast agents can be essential. Their application is subject to local medico-legal regulations and to their appropriateness to assist the diagnosis and therapy planning as judged by a trained physician. 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 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature is provided with a 70 cm magnet. ScanWise Implant functionality enables MR technologists to implement an improved and controlled workflow for MR Conditional implants. The feature consists of an extension to the Patient Registration User Interface where the information relevant to MR Conditional device labeling can be assessed, controlled and reviewed. The ScanWise Implant feature allows the user at the examination level to define restrictions on the 'active fields' generated by the MR system. The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature also consolidates separately-cleared novel functionalities, and minor hardware and software changes since the clearance of the currently marketed and predicate device, Ingenia R4 (K110151, 03/22/2011). Following minor hardware and software changes are covered in this submission: 1. (Hardware) Enhanced Patient Communication User Interface Module, IEC/ISO compliant symbols. 2. (Hardware) New computing platform and peripherals for MR Spectrometer (DDAS). 3. (Software) User Interface layout modifications for scan preparation, sequence planning (geometries and parameters), and data processing and viewing. 4. (Software) Planning on cine images. 5. (Software) SAR related parameters (SED). Pregnancy status related to Normal Mode. 6. (Software) Parameter optimization for the reconstruction algorithms. 7. (Software) Partial NSA algorithm in reconstruction. 8. (Software) AutoVoice, using pre-recorded spoken instructions. 9. (Software) VCG, optimized electrode placement and enhanced algorithm. 10. (Software) ComforTone: mechanical resonance frequency dependent timing adjustments of sequences for lower acoustic noise. 11. Enhanced sequences: a. AutoSpair. b. TSE flow compensation enhancement. c. Optimized 3D TSE flip angle sweeps per anatomy. d. ENCASE: 3D encoding. e. CardiacQuant: triggered T1 mapping sequence. f. pCASL. g. DTI enhancements.