# K071611: Neocoil 3.0T 8-Channel Shoulder Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: Neocoil
- Decided: Jun 28, 2007 after 15 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: 2 generations back to K945778 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042009: Mark Iii Phased Array Shoulder Coil, Usa Instruments, Inc. (2004) Summary page 2.
- K071311: Neocoil 1.5T 8-Channel Shoulder Array Coil, Neocoil (2007) Summary page 2.

## Most influential descendants
- K201101: 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil (2020), 0 descendants of its own

## Indications for use
To be used in conjunction with 3.OT GE HD series Magnetic Resonance scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K071611
Methodology: https://510kreport.com/methodology