Intended Use

The Polarean XENOVIEW 3.0T Chest Coil is to be used in conjunction with compatible 3.0T Magnetic Resonance Imaging (MRI) scanners and approved xenon Xe 129 hyperpolarized for oral inhalation for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.

Technology

The device is a flexible, single channel transmit-receive RF coil tuned to the 129Xe frequency on a 3.0T MRI magnetic field for imaging hyperpolarized 129Xe nuclei. The coil includes durable circuitry enclosed in non-conductive, flame-rated materials with padding for patient comfort, and uses fixed matching and tuning to eliminate the need for operator tuning.

Performance

Non-clinical bench testing was conducted including performance testing per NEMA and IEC standards for signal-to-noise ratio, specific absorption rate, RF coil heating, electrical safety, EMC, and biocompatibility per ISO standards. No clinical testing was required to demonstrate substantial equivalence. Testing confirmed the device is as safe and effective as its predicate device.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    10/22/2024

    28 days
  • 2

    FDA Approval

    11/19/2024

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