# K990550: 3.0T Signa VH/I Magnetic Resonance System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: May 11, 1999 after 78 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.
107 later devices descend from it; 2 cite it directly.
3 of 108 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 CV/i Magnetic Resonance System: named in the summary without a submission number

## Most influential descendants
- K022397: Signa 3.0T Magnetic Resonance System (2002), 104 descendants of its own
- K030874: GE 3.0T Signa Infinity Twinspeed with Excite MR System (2003), 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 VH/i system is a head-only scanner designed to support higher resolution imaging and shorter scan times. The Signa VH/i 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.. The images produced by the Signa VH/i 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/K990550
Methodology: https://510kreport.com/methodology