# K963429: Magnetic Resonance Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 27, 1996 after 89 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 Horizon HiSpeed MR System: named in the summary without a submission number
- (no number) Signa Horizon Fast Gradient Echo pulse sequence: named in the summary without a submission number

## Indications for use
SmartPrep IA option enables breath hold studies and trigger acquisition based on timing related to the arrival of a user injected exogenous contrast agent bolus.

Source page: https://510kreport.com/device/K963429
Methodology: https://510kreport.com/methodology