# 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

- Pathway: 510(k) (Traditional)
- Applicant: Neocoil, LLC
- Decided: Mar 11, 2022 after 108 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: 12 generations back to K971684 (1997). 27 ancestors in all.
No later device cites it as a predicate yet.
5 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143389: 3.0T GEM RT Open Array, Ge Healthcare Coils (Usa Instruments, Inc.) (2015) Summary page 4.

## Indications for use
The 32Ch AIR Open Coil Suite are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended to be used by trained medical professionals, for adult patients, in combination with and controlled by 1.5T or 3.0T GE Healthcare MRI system software. The 32Ch AIR Open Coil Suite is intended for use with specified couchtop and patient immobilization devices depending on the region of interest. When used as intended, the 32Ch AIR Open Coil Suite is used to produce diagnostic images of the head, neck, and brachial plexus structures. The images can be interpreted by medical professionals or facilitate Radiation Therapy (RT) planning.

Source page: https://510kreport.com/device/K213687
Methodology: https://510kreport.com/methodology