Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
Philips Medical Systems Nederland B.V.The Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems by Philips are advanced 1.5 and 3.0 Tesla MRI machines that produce high-quality cross-sectional images to help physicians diagnose various conditions. They include AI-enhanced features like SmartSpeed AI for faster image acquisition without loss of quality, aiding clinicians with quicker and improved diagnostic imaging.
Intended Use
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.
Technology
The device uses 1.5T and 3.0T magnetic fields to produce MR images based on relaxation signals from atomic nuclei; key components include magnet, transmit body coil, gradient coil, and RF amplifier. It incorporates software enhancements such as SmartSpeed AI combining compressed sensing with machine learning to accelerate image acquisition with equivalent or better image quality. Hardware enhancements include introduction of a GPU for image reconstruction.
Performance
Performance was validated via non-clinical verification and validation tests including pixel-wise comparisons with ground truth data demonstrating SmartSpeed AI's superior image quality at high accelerations and low SNR. Radiologist reader studies confirmed equivalent or better image quality versus longer scan times without AI. Risk management showed acceptable residual risk.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/12/2021
6 months - 2
FDA Approval
5/16/2022
Other devices from Philips Medical Systems Nederland B.V.
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