# K040640: Model 475 - 8 Channel T/R Phased Array Lower Extremity Coil

- Pathway: 510(k) (Traditional)
- Applicant: Igc-Medical Advances, Inc.
- Decided: Mar 22, 2004 after 12 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.
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) GE Signa 1.5T system: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K040640
Methodology: https://510kreport.com/methodology