# K983109: Model 545G-64 Pahased Array Musculoskeletal Flex Coil Package Model 543GE-64: Phased Array Upper Extrenity Flex Coil Any

- Pathway: 510(k) (Traditional)
- Applicant: Medical Advances, Inc.
- Decided: Oct 6, 1998 after 32 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K091902: 1.5T 8-Channel Small Extremity Coil, Model 800494, 3.0T 8-Channel Small Extremity Coil, Model 800484 (2009), 3 descendants of its own
- K162863: dS Small Extremity 16CH 1.5T Coil (2016), 2 descendants of its own
- K213766: dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T (2021), 1 descendant of its own
- K262294: dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T (2026), 0 descendants of its own

## Indications for use
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the bones, soft tissue, musculoskeletal structures and vascular structures of the upper and lower extremities.

Source page: https://510kreport.com/device/K983109
Methodology: https://510kreport.com/methodology