# K950973: Magnetic Resonance Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: May 11, 1995 after 70 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Vectra: named in the summary without a submission number
- (no number) Signa Advantage MR Systems: named in the summary without a submission number

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0616-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

## Indications for use
The Signa Contour 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 Contour System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NIVIR properties that determine the image appearance are proton density, relaxation time (T1), spin-spin relaxation time J2) and flow. When spin-lattice interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K950973
Methodology: https://510kreport.com/methodology