# K143389: 3.0T GEM RT Open Array

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Coils (Usa Instruments, Inc.)
- Decided: Mar 6, 2015 after 100 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: 11 generations back to K971684 (1997). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123327: 1.5T Gem RT Open Array, Ge Healthcare Coils (Usa Instruments, Inc.) (2013) Summary page 4.

## Most influential descendants
- K213687: 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch (2022), 0 descendants of its own

## Indications for use
The 3.0T GEM RT Open Array Coil, part of the Oncology Suite, is a receive-only RF coil designed for use with 3.0T MRI systems manufactured by GE. The indications for use include the head, neck, and brachial plexus anatomies and vasculature imaging. The nucleus excited is hydrogen.

Source page: https://510kreport.com/device/K143389
Methodology: https://510kreport.com/methodology