The Ingenia MR system family by Philips includes 1.5T and 3.0T MRI scanners that produce detailed cross-sectional and spectroscopic images of the body. It helps physicians diagnose and plan treatments by providing high-quality images of the head, body, and extremities. The system features an AI-based image reconstruction software called SmartSpeed Precise, which improves image sharpness and signal-to-noise ratio while reducing artifacts, enhancing image quality without changing intended use or safety.
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device 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 depends on tissue properties, scan technique, and contrast agents. Images assist in diagnosis and treatment planning.
Ingenia MR Systems include 60 cm and 70 cm bore 1.5T and 3.0T MR scanners with unchanged principal components compared to predicate devices. They incorporate a new optional AI imaging reconstruction software feature called SmartSpeed Precise, combining denoisers to enhance signal-to-noise ratio, sharpness, and reduce ringing artifacts in MR images. This software improves image quality without impacting device safety or indications and offers adjustable noise reduction levels.
Non-clinical performance testing complies with recognized standards. Validation included qualitative and reader evaluations by ABR-certified radiologists comparing SmartSpeed Precise to predicate devices for signal-to-noise ratio, artifact level, sharpness, contrast-to-noise ratio, and visualization of pathology. The results showed improved image quality and equivalent diagnostic capability without introducing new risks. Risk management confirmed acceptable overall residual risks.
No predicate devices specified
Submission
5/6/2025
FDA Approval
6/4/2025
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