# K042009: Mark Iii Phased Array Shoulder Coil

- Pathway: 510(k) (Special)
- Applicant: Usa Instruments, Inc.
- Decided: Aug 11, 2004 after 16 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: 1 generation back to K945778 (1995). 2 ancestors in all.
2 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)
- K010946: Mark 9000 Phased Array Shoulder Coil, Usa Instruments, Inc. (2001) Summary page 2.
- K945778: Phased Array Shoulder Coil, Quadrature Shoulder Coil, Medical Advances, Inc. (1995) Summary page 2.

## Most influential descendants
- K071611: Neocoil 3.0T 8-Channel Shoulder Array Coil (2007), 1 descendant of its own
- K201101: 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil (2020), 0 descendants of its own

## Indications for use
The Mark III Phased Array Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and adjacent regions in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Mark III Phased Array Coil is designed for use with the Signa EXCITE 3.0T MRI scanner manufactured by GE Medical Systems, Inc

Source page: https://510kreport.com/device/K042009
Methodology: https://510kreport.com/methodology