# K182261: NvisionVLE Imaging System, NvisionVLE Optical Probe

- Pathway: 510(k) (Special)
- Applicant: Ninepoint Medical, Inc.
- Decided: Oct 16, 2018 after 56 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: 8 generations back to K895614 (1989). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143678: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory, Ninepoint Medical, Inc. (2015) Summary page 5.

## Most influential descendants
- K191117: NvisionVLE Low-profile Optical Probe (2019), 0 descendants of its own

## Indications for use
The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization.

Source page: https://510kreport.com/device/K182261
Methodology: https://510kreport.com/methodology