510(k) · Cleared
Cleared8 Channel Cardiac Phased Array Coil
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 Jun 23, 2010 as substantially equivalent to K032045 (GE Medical Systems, 2003) and 1 other predicate after a 22-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Jun 23, 2010
- Review
- 22 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K971667 (1997). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK971667 Cardiac Phased Array CoilGE Medical Systems · 1997
- 3 generations backK022669 8 Channel Cardiac Phased Array CoilGE Medical Systems · 2002
- 2 generations backK031209 GE 1.5T 8 Channel Torso CoilGe Medical Systems, Inc. · 2003
- 1 generation backK052584 1.5T 12 Channel Body ArrayUsa Instruments, Inc. · 2005
- This deviceK101492 8 Channel Cardiac Phased Array CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971667 | Cardiac Phased Array Coil | GE Medical Systems | 1997 | — |
| −3 | K022669 | 8 Channel Cardiac Phased Array Coil | GE Medical Systems | 2002 | — |
| −2 | K031209 | GE 1.5T 8 Channel Torso Coil | Ge Medical Systems, Inc. | 2003 | — |
| −1 | K052584 | 1.5T 12 Channel Body Array | Usa Instruments, Inc. | 2005 | — |
| 0 (this device) | K101492 | 8 Channel Cardiac Phased Array Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K032045 | 8 Channel Cardiac Phased Array CoilSummary page 1…onance, specialty Classification Names: 21 CFR 892. 1000, Magnetic resonance diagnostic device Product Code: 90M0S Predicate Device(s): (1) K032045, 8 Channel Cardiac Phased Array Coil (2) K05258~4, 1.5T 12 Channel Body Array Device Descript… | 2003 |
| * | K052584 | 1.5T 12 Channel Body ArraySummary page 2…Coil has not been modified to accommodate the new anatomical region. Comparison with 1.5T 12 Channel Body Array Coil (K052584): The 8 Channel Cardiac Phased Array Coil is an existing device which will now… | 2005 |
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 13 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 8 ancestors has a 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. 2010, 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 8 Channel Cardiac Phased Array Coil is a receive-only RF Coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The indications for use include imaging of the heart, mediastinum, and pelvis regions for 2D and 3D Magnetic Resonance imaging. The nucleus excited is hydrogen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101492: 8 Channel Cardiac Phased Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101492
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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