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The RF coils when used in conjunction with the MRI systems or RF coils when used with the incubator system and both the incubator and RF coils used in conjunction with the MRI systems provide imaging of the adult head, extremity, neonate head and body. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

Device function is similar to the predicate devices, and in general any RF coil for MRI.

Advanced Imaging Research, Inc. intends to introduce Quadrature, Volume Coils for adult and pediatric MR. Specifically, Improved Adult Head coils, and Neonate Head and Body Volume coils safe for use with MRI compatible incubator systems are enclosed.

Our Improved Adult Head Coils provide enhanced signal-to-noise ratio (SNR), a high degree of RF homogeneity and is "open" to alleviate patient claustrophobia.

Our Neonate Coils are intended to scan pre- and term neonates and are designed for use with MR compatible incubator systems. The Neonate Head coil is intended to scan the newborn brain, whereas the Neonate Body coil is intended to scan the major organs (heart, spine, abdomen, pelvis etc.) in the torso and extremities.

This document is a 510(k) premarket notification for RF coils used in Magnetic Resonance Imaging (MRI). It does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria. Instead, it asserts that the device's function and technological characteristics are "similar" or "identical" to predicate devices already on the market.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to existing devices, rather than presenting a performance study with specific acceptance criteria.

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