# K002611: Signa Mfo/I Magnetic Resonance System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Oct 31, 2000 after 70 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (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; 2 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
- K033504: GE 0.35T Signa Ovation with Excite MR System (2003), 1 descendant of its own
- K053009: GE 0.35T Signa Ovation with Excite MR System (2005), 0 descendants of its own
- K023442: Extra Large Body Coil (2002), 0 descendants of its own

## Recalls of this device
- Aug 23, 2010 · Not classified · Z-0426-2011: If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury.
- Dec 31, 2006 · Not classified · Z-0170-2008: Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.

Source page: https://510kreport.com/device/K002611
Methodology: https://510kreport.com/methodology