# K163622: Lung Vision

- Pathway: 510(k) (Traditional)
- Applicant: Bodyvision Medical, Ltd.
- Decided: May 11, 2017 after 140 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: 7 generations back to K890348 (1989). 37 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062650: EP Navigator Software, Philips Medical Systems (2006) Summary page 4.

## Most influential descendants
- K172418: OpenSight (2018), 5 descendants of its own
- K221796: Cyware 4H and Cysart 4H (2022), 1 descendant of its own
- K213128: IntraOp VSP Software Device (2022), 1 descendant of its own
- K243069: Lumys (V1) (2025), 0 descendants of its own
- K232189: OrionXR (2023), 0 descendants of its own

## 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/K163622
Methodology: https://510kreport.com/methodology