510(k) · Cleared
Recalled · Class II · 2019AIR Anterior Array, AIR Posterior Array
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 Nov 22, 2017 after a 76-day review. The FDA summary names no predicate by number. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 22, 2017
- Review
- 76 days
- Class
- Class II
- Product code
- MOS
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK172695 AIR Anterior Array, AIR Posterior ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2017
- Descendant · cites it directly · 1 of its ownK182590 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AAGE Healthcare · 2018
- Descendant · 2 generations on · 0 of its ownK223378 3.0T 16ch AIR AAGe Healthcare Coils (Usa Instruments, Inc.) · 2023
- Descendant · cites it directly · 0 of its ownK182504 3.0T Air MP M, 3.0T Air MP LGe Healthcare Coils (Usa Instruments, Inc.) · 2018
Most influential descendants
Showing 3 of 3 · See all- K1825901.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AAGE Healthcare · 2018 · cites it directly1descendant
- K2233783.0T 16ch AIR AAGe Healthcare Coils (Usa Instruments, Inc.) · 2023 · 2 generations on0descendants
- K1825043.0T Air MP M, 3.0T Air MP LGe Healthcare Coils (Usa Instruments, Inc.) · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K172695 | AIR Anterior Array, AIR Posterior Array | Ge Healthcare Coils (Usa Instruments, Inc.) | 2017 | — |
| +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 | — |
| +2 | K223378 | 3.0T 16ch AIR AA | Ge Healthcare Coils (Usa Instruments, Inc.) | 2023 | — |
| +1 | K182504 | 3.0T Air MP M, 3.0T Air MP L | Ge Healthcare Coils (Usa Instruments, Inc.) | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
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?
The FDA summary names no predicate by number.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2019 | Class II | Z-0062-2020 | Device Design | 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 the internal porous material cannot… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K182590 (GE Healthcare, 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172695: AIR Anterior Array, AIR Posterior Array.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172695
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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