# K201101: 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil

- Pathway: 510(k) (Traditional)
- Applicant: Neocoil, LLC
- Decided: Jun 2, 2020 after 39 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 K945778 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071611: Neocoil 3.0T 8-Channel Shoulder Array Coil, Neocoil (2007) Summary page 5.

## Indications for use
To be used in conjunction with GEHC 1.5T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician. To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K201101
Methodology: https://510kreport.com/methodology