# K253738: 3.0T Air 32CH Hna

- Pathway: 510(k) (Abbreviated)
- Applicant: Ge Healthcare Coils (Usa Instruments, Inc.)
- Decided: Jan 23, 2026 after 60 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: 16 generations back to K971684 (1997). 33 ancestors in all.
No later device cites it as a predicate yet.
5 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180666: 48CH Head Coil, Ge Healthcare Coils (Usa Instruments, Inc.) (2018) Summary page 5.

## Indications for use
The 3.0T AIR™ 32CH HNA is a receive-only RF Coil designed for use with GE HealthCare 3.0T MRI systems. The coil is indicated for high-resolution magnetic resonance imaging (MRI) of the head and brain. When used with a Posterior Array in the MRI System patient table it also includes neck, cervical spine, neurovascular structures, upper thoracic spine, and brachial plexus imaging. The nucleus detected is hydrogen.

Source page: https://510kreport.com/device/K253738
Methodology: https://510kreport.com/methodology