# K182616: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

- Pathway: 510(k) (Traditional)
- Applicant: Ninepoint Medical, Inc.
- Decided: Nov 2, 2018 after 42 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: 19 generations back to K943450 (1995). 373 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 375 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153479: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System, Ninepoint Medical, Inc. (2016) Summary page 5.

## Most influential descendants
- K251730: LIA Console  (542-7) (2025), 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 and may be used to mark areas of tissue. The software provides segmentation and display of common imaging features, including hyper-reflective surface, layering, and hypo-reflective structures. The NvisionVLE® Imaging System is intended to provide an image of tissue microstructure. 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/K182616
Methodology: https://510kreport.com/methodology