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 Nov 19, 2024 as substantially equivalent to K231647 (Polarean, Inc., 2023) after a 28-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- Nov 19, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K061952 (2006). No later device cites it as a predicate yet.
- Root · 3 generations backK061952 Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32…Invivo · 2006
- 2 generations backK212239 XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2022
- 1 generation backK231647 XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2023
- This deviceK243316 XENOVIEW 3.0T Chest CoilPolarean, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K061952 | Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and… | Invivo | 2006 | — |
| −2 | K212239 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2022 | — |
| −1 | K231647 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2023 | — |
| 0 (this device) | K243316 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K231647 | XENOVIEW 3.0T Chest CoilSummary page 5…lass II Regulation Number: 21 CFR 892.1000 Classification Panel: Radiology Product Code: MOS Prior Submissions: K231647 Predicate Device: Trade Name Polarean XENOVIEW 3.0T Chest Coil 510(k) Submitter / Holder Pola… | 2023 |
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 18 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 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. 2024, 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 as stated in the FDA summary.
https://510kreport.com/device/K243316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243316: 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/K243316
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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