# K172695: AIR Anterior Array, AIR Posterior Array

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Coils (Usa Instruments, Inc.)
- Decided: Nov 22, 2017 after 76 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K182590: 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA (2018), 1 descendant of its own
- K223378: 3.0T 16ch AIR AA (2023), 0 descendants of its own
- K182504: 3.0T Air MP M, 3.0T Air MP L (2018), 0 descendants of its own

## Recalls of this device
- Mar 19, 2019 · Class II · Z-0062-2020: The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user and/or patient contact with infectious agents since

## Indications for use
The AIR Anterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. When used with other coils, the indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone imaging. The nucleus detected is hydrogen. The AIR Posterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. The indications for use include spine. When used with other coils, the indications for use also include abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging. The nucleus detected is hydrogen.

Source page: https://510kreport.com/device/K172695
Methodology: https://510kreport.com/methodology