Search Results

The intended use of the ClearMRI Helios-RG8 Coil Accessory Kit is to enable the GE Signa Horizon Cx MR System to perform MR scans of the head or body utilizing newer FDA-cleared coils (up to 8 channels), without hindering its current capability utilizing the legacy GE FDA-cleared 4-channel coils. The ClearMRI Helios-RG8 Coil Accessory Kit inherits the same limitations of the GE Signa Horizon Cx MR system. The ClearMRI Helios-RG8 Coil Accessory Kit has only been validated for and is for use strictly with the GE Signa Horizon Cx MR System, software build 9.1.0311b. The ClearMRI Helios-RG8 Coil Accessory Kit allows the GE Signa Horizon Cx MR System to continue to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body with the GE Signa Horizon Cx MR System. The images produced 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 determining a diagnosis. The Helios-RG8 Coll Accessory Kit will support coil anatomies from Resonance Innovations, LLC: Long Bone Array in large (model 168GE1501). Accessories to medical devices are regulated under the same classification regulation as the device(s) with which they are intended to be used. The ClearMRI Helios-RG8 Coil Accessory Kit is intended to be used strictly as an accessory to the GE Signa Horizon Cx MR System, software build 9.1.0311b, and does not change the existing indications for the GE Signa Horizon Cx MR System (K962061).

The ClearMRI Solutions, Inc. Helios-RG8 Coil Accessory Kit is designed as an accessory to a previously cleared GE Signa Horizon Cx MR (K962061), software build 9.1.0311b, receiver subsystem with the main modification allowing the operator to use newer RF receive coils with up to 8 channels. The accessory includes a digital receiver, multi-coil driver, and a computer system containing the ClearMRI software and functions in a similar way to the predicate device's comparable subsystem. The ClearMRI hardware is seamlessly background-driven from the GE Signa Horizon Cx system'. The ClearMRI Solutions Helios-RG8 Coil Accessory Kit includes a digital receiver, multi-coil driver and a computer system containing the ClearMRI software. The accessory kit is available as an add-on to a GE Signa Horizon Cx MR, software build 9.1.0311b, receiver subsystem that allows the operator to scan using a digital imaging system resulting in the benefits of newer multi-channel RF coils. The ClearMRI hardware is controlled by software running independently and in parallel with the GE Signa Horizon Cx System. It does not alter the existing operator workflow. The Helios-RG8 has no new technological characteristics that raise new safety or effectiveness questions.