# K162623: 16ch T/R Hand Wrist Coil

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics, LLC
- Decided: Dec 9, 2016 after 80 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: 6 generations back to K893619 (1989). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103149: 1.5T 16-Channel Hand-Wrist Coil, Invivo Corporation (2011) Summary page 4.
- K150331: 18ch T/R Knee Coil, Quality Electrodynamics, LLC (2015) Summary page 4.

## Most influential descendants
- K173469: 16ch T/R Hand Wrist Coil (2018), 0 descendants of its own

## Indications for use
The 16ch T/R Hand Wrist Coil is intended for use with GE 3.0T MR systems to produce diagnostic images of the hand and wrist that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K162623
Methodology: https://510kreport.com/methodology