# K013592: Extremity Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Jan 8, 2002 after 70 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: 4 generations back to K893619 (1989). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994040: Phased Array Knee and Foot Coil, Usa Instruments, Inc. (2000) Summary page 2.
- K971246: Leo 7000 Quadrature Knee Coil, Usa Instruments, Inc. (1997) Summary page 2.

## Indications for use
The Extremity Coil is a receive-only specialty RF coil, used for obtaining diagnostic images of the knee and foot in Magnetic Resonance Imaging systems. The Extremity Coil is designed for use with the Siemens Rhapsody 1.0Tesla MRI scanner manufactured by Siemens Medical Systems, Inc. Anatomic Regions: Shoulder and surrounding regions. Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Siemens Rhapsody MRI 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/K013592
Methodology: https://510kreport.com/methodology