510(k) · Cleared
Cleared3.0T Air 32CH Hna
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 23, 2026 as substantially equivalent to K180666 (Ge Healthcare Coils (Usa Instruments, Inc.), 2018) after a 60-day review. Its family tree reaches back 16 generations to 1997. 5 of the 34 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 23, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K971684 (1997). 33 ancestors in all, the oldest K962061 (1996). No later device cites it as a predicate yet. 5 of the 34 devices in this family, counting this one, have a Class I recall.
- Root · 16 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 12 generations between
- 3 generations backK143345 SIGNA PioneerGe Healthcare Japan Corporation · 2015 · Recalled
- 2 generations backK163205 48CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2017
- 1 generation backK180666 48CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2018
- This deviceK253738 3.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.) · 2026
Show all 16 generations
- Root · 16 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 15 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 14 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 13 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 12 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 11 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 10 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 9 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 8 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- 7 generations backK113490 Optima MR450WGe Medical Systems, LLC · 2012 · Recalled
- 6 generations backK123522 Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 5 generations backK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 4 generations backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
- 3 generations backK143345 SIGNA PioneerGe Healthcare Japan Corporation · 2015 · Recalled
- 2 generations backK163205 48CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2017
- 1 generation backK180666 48CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2018
- This deviceK253738 3.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.) · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −15 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −14 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −13 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −12 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −11 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −10 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| −9 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| −8 | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | 8 |
| −7 | K113490 | Optima MR450W | Ge Medical Systems, LLC | 2012 | 3 |
| −6 | K123522 | Optima MR450W | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 1 |
| −5 | K132376 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima… | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 15 |
| −4 | K142085 | Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W… | Ge Medical Systems, LLC | 2014 | 27 |
| −3 | K143345 | SIGNA Pioneer | Ge Healthcare Japan Corporation | 2015 | 6 |
| −2 | K163205 | 48CH Head Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2017 | — |
| −1 | K180666 | 48CH Head Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2018 | — |
| 0 (this device) | K253738 | 3.0T Air 32CH Hna | Ge Healthcare Coils (Usa Instruments, Inc.) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 4 | 1 |
| 2002 | 2 | 1 |
| 2003 | 1 | 1 |
| 2004 | 1 | 1 |
| 2005 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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.
5 devices in this family have a Class I recall. 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 K233444 InkSpace Imaging Small Body Arrayscore 14.1 · 6 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 |
|---|---|---|---|
| * | K180666 | 48CH Head CoilSummary page 5…mmon/Usual Name: Coil, Magnetic Resonance, Specialty Product Code: MOS Predicate Device: 48CH Head Coil (K180666) Device Description: The 3.0T AIR 32CH HNA is a receive-only radio frequency coil engineered to deliver optimal… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 9 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 10 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 11 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 11 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 12 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 24 of the 33 ancestors have a recall of any class; 5 have a Class I recall.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253738: 3.0T Air 32CH Hna.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253738
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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