# K963179: Magnetic Resonance Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 7, 1996 after 85 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.
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) Signa SP System: named in the summary without a submission number

## Indications for use
The Signa SP System optional accessories are indicated for use as follows: The Scan Plane Pointer facilitates localization of the scanning planes. The side entry patient support access feature and the Patient Imaging Chair allows multiple patient positions enabling imaging exams of dynamic joints (such as knees and shoulders) and loaded spine studies. The use of MR Imaging during interventional procedures using common devices such as fine needles and suction.

Source page: https://510kreport.com/device/K963179
Methodology: https://510kreport.com/methodology