510(k) · Cleared
ClearedCardiac Phased Array Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jul 23, 1997 after a 78-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Jul 23, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK971667 Cardiac Phased Array CoilGE Medical Systems · 1997
- Descendant · cites it directly · 5 of its ownK022669 8 Channel Cardiac Phased Array CoilGE Medical Systems · 2002
- Descendant · cites it directly · 4 of its ownK030495 3.0T Torso Phased Array CoilGe Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK031209 GE 1.5T 8 Channel Torso CoilGe Medical Systems, Inc. · 2003
- Descendant · 3 generations on · 1 of its ownK052584 1.5T 12 Channel Body ArrayUsa Instruments, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK032045 8 Channel Cardiac Phased Array CoilGE Medical Systems · 2003
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K0226698 Channel Cardiac Phased Array CoilGE Medical Systems · 2002 · cites it directly5descendants
- K0304953.0T Torso Phased Array CoilGe Medical Systems, Inc. · 2003 · cites it directly4descendants
- K031209GE 1.5T 8 Channel Torso CoilGe Medical Systems, Inc. · 2003 · 2 generations on3descendants
- K0525841.5T 12 Channel Body ArrayUsa Instruments, Inc. · 2005 · 3 generations on1descendant
- K0320458 Channel Cardiac Phased Array CoilGE Medical Systems · 2003 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971667 | Cardiac Phased Array Coil | GE Medical Systems | 1997 | — |
| +1 | K022669 | 8 Channel Cardiac Phased Array Coil | GE Medical Systems | 2002 | — |
| +1 | K030495 | 3.0T Torso Phased Array Coil | Ge Medical Systems, Inc. | 2003 | — |
| +2 | K031209 | GE 1.5T 8 Channel Torso Coil | Ge Medical Systems, Inc. | 2003 | — |
| +3 | K052584 | 1.5T 12 Channel Body Array | Usa Instruments, Inc. | 2005 | — |
| +2 | K032045 | 8 Channel Cardiac Phased Array Coil | GE Medical Systems | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | — | ScanMed Cardiac/Vascular Coil Named without a submission number | |
| * | — | GE Pelvic Phased Array Coil Named without a submission number |
What descends from it? (7)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022669 (GE Medical Systems, 2002) has gone furthest, with 5 descendants 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.
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?
It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging
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/K971667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971667: 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/K971667
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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