510(k) · Cleared
ClearedXENOVIEW 3.0T Chest Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polarean, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Dec 23, 2022 as substantially equivalent to K061952 (Invivo, 2006) after a 522-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it.
- Decided
- Dec 23, 2022
- Review
- 522 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061952 (2006). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK061952 Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32…Invivo · 2006
- This deviceK212239 XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK231647 XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK243316 XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061952 | Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and… | Invivo | 2006 | — |
| 0 (this device) | K212239 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2022 | — |
| +1 | K231647 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2023 | — |
| +2 | K243316 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K061952 | Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and Cac-127-16Summary page 4…odels CAC-63-16, CAC-63-32, CAC-123-32, and CAC-127-16 510(k) Submitter / Holder INVIVO 510(k) Number K061952 Regulation Number 21 CFR 892.1000 Magnetic resonance diagnostic device Classification Clas… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231647 | XENOVIEW 3.0T Chest Coil | 2023 | 1 |
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?
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Polarean XENOVIEW 3.0T Chest Coil is to be used in conjunction with compatible 3.0T Magnetic Resonance Imaging (MRI) scanners and approved xenon Xe 129 hyperpolarized for oral inhalation for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.
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/K212239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212239: XENOVIEW 3.0T Chest Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212239
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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