# K040288: QSC-127-Int Shoulder Array Coil Set

- Pathway: 510(k) (Special)
- Applicant: Mri Devices Corp.
- Decided: Mar 5, 2004 after 28 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080120: Hfo Shoulder Coil (2008), 0 descendants of its own

## Indications for use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K040288
Methodology: https://510kreport.com/methodology