# K980114: Magnetic Resonance Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Mar 30, 1998 after 76 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
No predicates in its family tree.
104 later devices descend from it; 1 cites it directly.
3 of 105 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

## Indications for use
The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa CVMR system 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.

Source page: https://510kreport.com/device/K980114
Methodology: https://510kreport.com/methodology