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The Supernova C5 is intended for use as a diagnostic imaging device which can produce transverse, sagittal, coronal and oblique cross-sectional images of the internal structure of the human head, body or extremities. The images produced by MRI system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination

The Supernova C5 is a 0.35T permanent magnet MRI system. It is composed of Magnet and Magnet Enclosure, RF Coils , Patient Couch, System Cabinet, computer system. The system software based on Windows XP or Windows 7 is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.

The provided text is a 510(k) summary for the Supernova C5 MRI System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and detailed study results in the manner requested. The document does not contain the level of detail needed to complete all aspects of the request.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for image quality or clinical performance that the device must meet beyond compliance with recognized consensus standards. It lists various standards (IEC 60601-1, IEC 60601-2-33, MS 1-2008 to MS 9-2008, NEMA PS3.1-3.20 (2011)) that the device has been designed to comply with. These standards often contain performance requirements (e.g., for SNR, geometric distortion, uniformity, acoustic noise, SAR, dB/dt).

The reported performance is primarily relative to the predicate device and the safety parameters:

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