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Used in a MR Scanner or used in the LMT nomag IC incubator and a MR Scanner, the Neonate Array Colls (receive only) are indicated for use as a diagnostic imaging device to provide transversal, sacittel, connel, and chical device to provide (rocolve only) are indicated for use as a diagnostic imaging structures of the structures of the - head (Neonate Head Array Coil) . - spine, torso (Neonate Body Array Coil). . When interpreted by a trained physician, these images provide information that can be useful in the determination of a diagnosis. The excited nucleus is 1H (Proton). The signal received by the coils is dependent upon the MRI parameters (T1 (Proton). Intice relaxation time. T2 as an and is dependent upon the MRI parameters (T1 or spinlattice relaxation time, T2 or spin-spin relaxation time, density of nuclei, flow velocity and chemical shift). The Neonate Array coils are compatible to Siemens and Philips MRTs with 1 ET or 3 oT MRTs with 1.5T or 3.0T.

The Neonate Array Coils (in the following NAC) is a phased array coil with rectangle loop design and integrated RF preamp per channel. It is a receive-only coil with rectangle for horizontal B-field scanners with field stars of for horizontal B-field scanners with field strengths of 1.5T of 3.0T.

The provided text does not contain a study or acceptance criteria for device performance. It is a 510(k) summary for the LMT Medical Systems GmbH Neonate Array Coils, which establishes substantial equivalence to a predicate device.

The document states that the "safety and performance parameters specified by the FDA guidance for MR Diagnostic Devices are met by the NAC," and lists "Imaging" under performance and various safety aspects. However, it does not provide specific acceptance criteria (e.g., target signal-to-noise ratio, image resolution, specific diagnostic accuracy metrics) or details of a study that evaluates the device's performance against such criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as this information is not present in the given text.

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