Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
Philips Medical Systems Nederland B.V.The Ingenia series MR Systems by Philips Medical Systems Nederland B.V. are advanced MRI devices that produce detailed cross-sectional images and spectra of the head, body, and extremities. Utilizing strong magnetic fields and radio signals, these systems aid physicians in diagnosing diseases, planning treatments, and guiding minimally invasive procedures by providing high-quality images. The new Precise Image software feature enhances image quality by employing deep learning to improve sharpness and reduce noise and artifacts, facilitating better clinical assessment.
Intended Use
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device enabling trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities representing the spatial distribution of nuclei with spin.
Technology
The device uses 1.5 and 3.0 Tesla magnetic fields and applies radio signals to excite atomic nuclei. The proprietary Precise Image software uses deep learning reconstruction techniques to increase signal-to-noise ratio, sharpness, and reduce ringing artifacts in MR images. The hardware components such as magnet and coils remain unchanged from predicates.
Performance
Non-clinical performance testing including compliance with IEC and ISO standards was conducted. Qualitative image reviews and reader evaluations by ABR board certified radiologists demonstrated improved signal-to-noise ratio, sharpness, and diagnostic equivalence or superiority compared to predicate devices. Risk management confirmed no new risks introduced.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/16/2022
4 months - 2
FDA Approval
4/6/2023
Other devices from Philips Medical Systems Nederland B.V.
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