# Ge Healthcare Coils (Usa Instruments, Inc.)

- Location (FDA's records): Aurora, OH
- FDA decisions: 12 (2009–2026): 12 510(k) clearances
- Product codes: MOS (11), KXH (1)
- 510(k) review time since 2016: median 58 days, against 52 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 13 (4 its own); citations of its devices by later devices: 8 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Usa Instruments, Inc.: 3 (https://510kreport.com/company/usa-instruments)
- GE Healthcare: 2 (https://510kreport.com/company/ge-healthcare)
- Octostop, Inc.: 1 (https://510kreport.com/company/octostop)
- Midwest Rf, LLC: 1 (https://510kreport.com/company/midwest-rf)
- Ge Healthcare Japan Corporation: 1 (https://510kreport.com/company/ge-healthcare-japan)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)

## Firms that cite its devices most
- Advanced Imaging Research Dba Sree Medical Systems: 1 (https://510kreport.com/company/advanced-imaging-research-dba-sree-medical-systems)
- Neocoil, LLC: 1 (https://510kreport.com/company/neocoil)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- Shanghai United Imaging Healthcare Co., Ltd.: 1 (https://510kreport.com/company/shanghai-united-imaging-healthcare)

## Its most-cited devices
- K172695: AIR Anterior Array, AIR Posterior Array (2017), cited by 2
- K163205: 48CH Head Coil (2017), cited by 2
- K180666: 48CH Head Coil (2018), cited by 1
- K093348: 3.0T 16 Channel Head Neck Spine Coil (2009), cited by 1
- K123327: 1.5T Gem RT Open Array (2013), cited by 1
- K143389: 3.0T GEM RT Open Array (2015), cited by 1

## Recent decisions
- K253738: 3.0T Air 32CH Hna (Jan 23, 2026)
- K223378: 3.0T 16ch AIR AA (Jan 3, 2023)
- K182504: 3.0T Air MP M, 3.0T Air MP L (Oct 12, 2018)
- K180666: 48CH Head Coil (Apr 12, 2018)
- K172695: AIR Anterior Array, AIR Posterior Array (Nov 22, 2017)
- K163205: 48CH Head Coil (Jan 12, 2017)
- K143389: 3.0T GEM RT Open Array (Mar 6, 2015)
- K123327: 1.5T Gem RT Open Array (Jan 11, 2013)

Source page: https://510kreport.com/company/ge-healthcare-coils-usa-instruments