# K260885: VERAFEYE Imaging and Guidance System (VF-VIS-002)

- Pathway: 510(k) (Traditional)
- Applicant: Luma Vision Limited
- Decided: Jun 15, 2026 after 90 days
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 31 generations back to K935595 (1995). 326 ancestors in all.
No later device cites it as a predicate yet.
0 of 327 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242893: VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System, Luma Vision Limited (2025) Summary page 6.
- K251234: EnSite™ X EP System, Abbott Medical (2025) Summary page 6.

## Indications for use
The VERAFEYE Imaging and Guidance System is intended for cardiac applications. The system provides 2D & 3D images of the heart, cardiac valves, great vessels, and surrounding anatomical structures for the evaluation of the presence or absence of pathology. The VERAFEYE Imaging and Guidance System is also intended for catheter-based cardiac electrophysiological (EP) procedures in the Left and Right Atrium. The VERAFEYE Imaging and Guidance System provides the reconstruction of chamber geometry from ultrasound data, and visualization of the chamber anatomy and intracardiac catheter location during procedures.

Source page: https://510kreport.com/device/K260885
Methodology: https://510kreport.com/methodology