# K013541: Shoulder Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Dec 14, 2001 after 51 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). 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)
- K983143: Mark 5000 Phased Array Shoulder Coil, Usa Instruments, Inc. (1998) Summary page 2.
- K945778: Phased Array Shoulder Coil, Quadrature Shoulder Coil, Medical Advances, Inc. (1995) Summary page 2.

## Indications for use
The Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and surrounding regions in Magnetic Resonance Imaging systems. The Shoulder Coil is designed for use with the Rhapsody (1.0 Tesla) 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 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/K013541
Methodology: https://510kreport.com/methodology