# K962061: Magnetic Resonance Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 27, 1996 after 183 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
106 later devices descend from it; 3 cite it directly.
3 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Signa Horizon System: named in the summary without a submission number

## Most influential descendants
- K012200: 1.5T Infinity Twinspeed MR System (2001), 103 descendants of its own
- K013636: Signa Infinity MR System with Excite Technology (2002), 100 descendants of its own
- K041476: GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System (2004), 99 descendants of its own
- K052293: GE 1.5T and 3.0T Signa HDX MR System (2005), 90 descendants of its own
- K081028: Signa 3.0T MR750 System (2008), 70 descendants of its own

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0617-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Nov 9, 2010 · Not classified · Z-1424-2011: GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patie

## Indications for use
The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, sagital, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclel) 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.

Source page: https://510kreport.com/device/K962061
Methodology: https://510kreport.com/methodology