# K954190: Model 580GE-64 Quadrature Abdominal Flex Coil

- Pathway: 510(k) (Traditional)
- Applicant: Medical Advances, Inc.
- Decided: Nov 20, 1995 after 75 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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.
11 later devices descend from it; 2 cite it directly.
0 of 12 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
- K093842: 1.5T and 3.0T General Purpose Flex Coils (2010), 7 descendants of its own
- K111673: 1.5T and 3T 8-Channel Medium General Purpose Flex Coil (2011), 5 descendants of its own
- K122897: Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model 800645 (2012), 3 descendants of its own
- K120122: Sense MSK S 8CH 1.5T (2012), 3 descendants of its own
- K212864: dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T (2021), 2 descendants of its own

Source page: https://510kreport.com/device/K954190
Methodology: https://510kreport.com/methodology