510(k) · Cleared
Cleared3.0T 16ch AIR AA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Coils (Usa Instruments, Inc.) · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jan 3, 2023 as substantially equivalent to K182590 (GE Healthcare, 2018) after a 57-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Jan 3, 2023
- Review
- 57 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K172695 (2017). No later device cites it as a predicate yet.
- Root · 2 generations backK172695 AIR Anterior Array, AIR Posterior ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2017 · Recalled
- 1 generation backK182590 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AAGE Healthcare · 2018
- This deviceK223378 3.0T 16ch AIR AAGe Healthcare Coils (Usa Instruments, Inc.) · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K172695 | AIR Anterior Array, AIR Posterior Array | Ge Healthcare Coils (Usa Instruments, Inc.) | 2017 | 1 |
| −1 | K182590 | 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA | GE Healthcare | 2018 | — |
| 0 (this device) | K223378 | 3.0T 16ch AIR AA | Ge Healthcare Coils (Usa Instruments, Inc.) | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182590 | 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AASummary page 4…ce Diagnostic Device Regulation Number: 21 CFR 892.1000 Product Code: MOS Predicate Device: 1.5T 16ch AIR AA (K182590) Device Description: The 3.0T 16ch AIR AA is a receive-only coil designed to provide optimum signal-to noise an… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The 3.0T 16ch AIR AA is a receive-only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images of general human anatomy, including extremities. The nucleus detected is hydrogen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223378 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223378: 3.0T 16ch AIR AA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223378
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026