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1.5T MRI systems are intended for use as NMR devices that produce images that (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Flexible Cardiac Coil is indicated for use with Philips 1.5T MRJ systems in the following anatomic regions and with the designated nuclei. Regions: Heart and associated structures in the thoracic region. Nuclei Excited: Hydrogen

Flexible Cardiac Coil

This is a 510(k) clearance letter for a "Flexible Cardiac Coil," which is a magnetic resonance diagnostic device. The letter focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information regarding specific acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria in terms of analytical or clinical performance. The letter confirms that the device can be marketed based on its substantial equivalence to other devices already on the market, but it does not include a performance study summary.

Therefore, I cannot provide the requested information based on the provided text. The document is strictly a regulatory clearance and does not delve into the technical performance evaluation that would typically be detailed in a submission summary for a device with an AI component or a new diagnostic capability.

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