# K994040: Phased Array Knee and Foot Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Jan 18, 2000 after 50 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
Longest line of descent: 3 generations back to K893619 (1989). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971246: Leo 7000 Quadrature Knee Coil, Usa Instruments, Inc. (1997) Summary page 2.
- K982496: Quadrature Lower Extremity Coil, Model # 473SI-42D, Medical Advances, Inc. (1998) Summary page 2.

## Most influential descendants
- K013592: Extremity Coil (2002), 0 descendants of its own

## Indications for use
The Phased Array Knee and Foot Coil is designed to provide Magnetic Resonance Images of the knee and foot anatomies. The Phased Array Knee and Foot Coil has been designed for use with the GE Signa HFO/i 0.7T scanner. Anatomic Regions: Knee and Foot Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Signa HFO/i 0.7T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K994040
Methodology: https://510kreport.com/methodology