3.0T 16ch AIR AA
FDA 510(k) K223378 · Ge Healthcare Coils (Usa Instruments, Inc.)
510(k) numberK223378
Submission
- Device name
- 3.0T 16ch AIR AA
- Applicant
- Ge Healthcare Coils (Usa Instruments, Inc.)
Aurora, OH, US - Received
- November 7, 2022
- Decision date
- January 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MOS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…MOS · Special | Philips Medical Systems Nederland B.V. | 07/30/2026SE |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…MOS · Special | Philips Medical Systems Nederland B.V. | 07/24/2026SE |
| K260947 | 0.55T 12Ch Breast CoilMOS · Special | Neocoil, LLC | 04/23/2026SE |
| K252587 | HD 8Ch Wrist ArrayMOS · Traditional | Shenzhen RF Tech Co., Ltd. | 04/14/2026SE |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive…MOS · Traditional | Shenzhen RF Tech Co., Ltd. | 04/01/2026SE |
| K260519 | Smart Fit TorsoCardiac 1.5TMOS · Special | Philips Healthcare (Suzhou) Co., Ltd. | 03/20/2026SE |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive…MOS · Traditional | Shenzhen RF Tech Co., Ltd. | 02/10/2026SE |
| K253738 | 3.0T Air 32CH HnaMOS · Abbreviated | Ge Healthcare Coils (Usa Instruments, Inc.) | 01/23/2026SE |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOS · Special | Philips Medical Systems Nederland B.V. | 01/14/2026SE |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x)MOS · Special | Inkspace Imaging, Inc. | 10/20/2025SE |
More from Inkspace Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253738 | 3.0T Air 32CH HnaMOS · Abbreviated | 01/23/2026SE |
| K182504 | 3.0T Air MP M, 3.0T Air MP LMOS · Traditional | 10/12/2018SE |
| K180666 | 48CH Head CoilMOS · Special | 04/12/2018SE |
| K172695 | AIR Anterior Array, AIR Posterior ArrayMOS · Traditional | 11/22/2017SE |
| K163205 | 48CH Head CoilMOS · Traditional | 01/12/2017SE |
| K143389 | 3.0T GEM RT Open ArrayMOS · Traditional | 03/06/2015SE |
| K123327 | 1.5T Gem RT Open ArrayMOS · Traditional | 01/11/2013SE |
| K122174 | Pediatric Positioner Pad SetKXH · Traditional | 11/16/2012SE |
| K103365 | Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array Coil…MOS · Traditional | 01/12/2011SE |
| K101492 | 8 Channel Cardiac Phased Array CoilMOS · Traditional | 06/23/2010SE |
Questions and answers
When was 3.0T 16ch AIR AA cleared by the FDA?
3.0T 16ch AIR AA (K223378) received a 510(k) decision of Substantially Equivalent on January 3, 2023, 57 days after the submission was received.
What is the product code of K223378?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.