The dS Knee Coil 8ch 1.5T is an 8-channel phased array MRI coil designed for use with Philips 1.5T MRI systems to produce high-resolution diagnostic images of the knee. The coil's design improves signal-to-noise ratio and patient comfort, enabling accurate imaging of knee anatomy for clinical evaluation by trained physicians.
The dS Knee Coil 8ch 1.5T is to be used in conjunction with Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of Knee that can be interpreted by a trained physician.
The device is an 8-channel phased array, receive-only coil with a rigid and anatomically contoured housing designed for knee imaging. It is compatible with Philips 1.5T Prodiva and MR 5300 MR Systems and features a split housing design with a single handle for easy setup and enhanced patient comfort.
The device underwent non-clinical testing for electrical safety, EMC immunity, image uniformity, biological safety, and cleaning validation following recognized standards, and clinical testing involved image quality assessment by a U.S. Board Certified radiologist confirming diagnostic quality images.
No predicate devices specified
Submission
9/23/2024
FDA Approval
10/18/2024
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