Intended Use

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.

Technology

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.

Performance

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.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    9/23/2024

    25 days
  • 2

    FDA Approval

    10/18/2024

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