# K132381: Clearmri Helios-RG8 Coil Accessory Kit

- Pathway: 510(k) (Traditional)
- Applicant: Clearmri Solutions, Inc.
- Decided: Apr 4, 2014 after 247 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962061 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962061: Magnetic Resonance Diagnostic System, GE Medical Systems (1996) Summary page 1.

## Indications for use
The intended use of the ClearMRl Helios-R08,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 ClearMRl Helios-RGS Coil Accessory Kit inherits the same limitations of the GE Signa Horizon Cx MR system. The ClearMRl 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 9.1.031 lb. The ClearMRl Helios-ROS Coil Accessory Kit allows the GE Signa Horizon Cx MR System to continue to produce transverse, sagittal, coronall 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 (TI), spin-spin relaxation time (72) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Helios-ROS Coil Accessory Kit will support coil anatomies from Resonance Innovations, LLC: Long Bone Array in large (model 168GEl150 1). Accessories to medical devices arc regulated under the same classification regulation as the device(s) with which they are intended to be used. The ClearMRl Helios-ROS Coil Accessory Kit is intended to be used strictly as an accessory to the GE Signa Horizon Cx MR System, software build 9.1.0311 b, and does not change the existing indications for the GE Signa Horizon Cx MR System (K962061I).

Source page: https://510kreport.com/device/K132381
Methodology: https://510kreport.com/methodology