# K240943: LungVision

- Pathway: 510(k) (Traditional)
- Applicant: Bodyvision Medical, Ltd.
- Decided: Oct 1, 2024 after 179 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 1 generation back to K183593 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183593: Lung Vision System, Bodyvision Medical, Ltd. (2019) Summary page 5.

## Indications for use
The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.

Source page: https://510kreport.com/device/K240943
Methodology: https://510kreport.com/methodology