MR 5300 and MR 7700 R11 MR Systems
Philips Medical Systems Nederlands B.V.The MR 5300 and MR 7700 R11 MR Systems by Philips are advanced magnetic resonance imaging (MRI) devices that provide high-quality images of the internal structures of the head, body, or extremities. These systems help clinicians by enabling detailed visualization, which supports diagnosis, therapy planning, and interventional procedures. The devices incorporate updated software (R11) and minor hardware enhancements, including AI-powered SmartSpeed features that improve image acquisition and reconstruction, facilitating faster and more accurate MRI scans.
Intended Use
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. The systems assist diagnosis and therapy planning and support interventional and minimally invasive procedures.
Technology
The MR 5300 and MR 7700 R11 MR Systems use 1.5T and 3.0T magnetic resonance technology with components including magnet, transmit body coil, gradient coil, gradient amplifier, RF amplifier, and patient support identical to predicate devices. Software R11 includes AI-enabled SmartSpeed features. Hardware enhancements include a graphical processing unit for image reconstruction and an additional monitor as part of the operating console.
Performance
Performance testing included non-clinical verification and validation tests to meet acceptance criteria and standards for safety and effectiveness. The systems comply with numerous international and FDA recognized standards. Clinical studies were not required due to substantial equivalence with predicate devices. Risks are mitigated to an acceptable level.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/14/2022
1 month - 2
FDA Approval
12/23/2022
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