# K942604: Signa Advantage SP Magnetic Resonance System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 24, 1995 after 541 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992892: Stepping Kinematic Imaging Platform (Skip) (1999), 0 descendants of its own
- K964969: Signa SP Crown Coils (Numbers 1 Through 3) (1997), 0 descendants of its own
- K964306: Magnetic Resonance Diagnostic Accessory (1997), 0 descendants of its own

## Recalls of this device
- Nov 9, 2010 · Not classified · Z-1425-2011: GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patie

Source page: https://510kreport.com/device/K942604
Methodology: https://510kreport.com/methodology