# K223071: Xenoview VDP

- Pathway: 510(k) (Traditional)
- Applicant: Polarean, Inc.
- Decided: Dec 23, 2022 after 84 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K954355 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103480: Thoracic Vcar, Ge Medical Systems, LLC (2011) Summary page 4.

## Indications for use
XENOVIEW VDP is image processing software that analyzes a pulmonary hyperpolarized 129-Xe MR image and a proton chest MR image to provide visualization and evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.

Source page: https://510kreport.com/device/K223071
Methodology: https://510kreport.com/methodology