# K251730: LIA Console  (542-7)

- Pathway: 510(k) (Traditional)
- Applicant: Leadoptik, Inc.
- Decided: Dec 19, 2025 after 196 days
- Product code: NQQ (System, Imaging, Optical Coherence Tomography (Oct))
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K943450 (1995). 374 ancestors in all.
No later device cites it as a predicate yet.
0 of 375 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182616: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System, Ninepoint Medical, Inc. (2018) Summary page 5.

## Indications for use
The LIA Console is indicated for use as an imaging tool in the evaluation of human tissue microstructure in the tracheobronchial tree by providing two-dimensional, cross-sectional, real-time depth visualization using Optical Coherence Tomography (OCT). The safety and effectiveness of this device for diagnostic analysis (i.e., differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated

Source page: https://510kreport.com/device/K251730
Methodology: https://510kreport.com/methodology