510(k) · Cleared
ClearedCardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and Cac-127-16
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jul 28, 2006 after an 18-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jul 28, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK061952 Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32…Invivo · 2006
- Descendant · cites it directly · 2 of its ownK212239 XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK231647 XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK243316 XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK183186 Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular…Shanghai United Imaging Healthcare Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK120290 Toshiba 1.5T Cardiac CoilQuality Electrodynamics · 2012
Most influential descendants
Showing 5 of 5 · See all- K212239XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2022 · cites it directly2descendants
- K231647XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2023 · 2 generations on1descendant
- K243316XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2024 · 3 generations on0descendants
- K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd. · 2019 · cites it directly0descendants
- K120290Toshiba 1.5T Cardiac CoilQuality Electrodynamics · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061952 | Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and… | Invivo | 2006 | — |
| +1 | K212239 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2022 | — |
| +2 | K231647 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2023 | — |
| +3 | K243316 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2024 | — |
| +1 | K183186 | Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil… | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
| +1 | K120290 | Toshiba 1.5T Cardiac Coil | Quality Electrodynamics | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 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, K212239 (Polarean, Inc., 2022) has gone furthest, with 2 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?
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular, pulmonary, renal, and abdominal systems that can be interpreted by a trained physician.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061952 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061952: Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and Cac-127-16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061952
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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