# K212239: XENOVIEW 3.0T Chest Coil

- Pathway: 510(k) (Traditional)
- Applicant: Polarean, Inc.
- Decided: Dec 23, 2022 after 522 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: 1 generation back to K061952 (2006). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061952: Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and Cac-127-16, Invivo (2006) Summary page 4.

## Most influential descendants
- K231647: XENOVIEW 3.0T Chest Coil (2023), 1 descendant of its own
- K243316: XENOVIEW 3.0T Chest Coil (2024), 0 descendants of its own

## 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/K212239
Methodology: https://510kreport.com/methodology