# K243316: XENOVIEW 3.0T Chest Coil

- Pathway: 510(k) (Special)
- Applicant: Polarean, Inc.
- Decided: Nov 19, 2024 after 28 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K061952 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231647: XENOVIEW 3.0T Chest Coil, Polarean, Inc. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K243316
Methodology: https://510kreport.com/methodology