# K191117: NvisionVLE Low-profile Optical Probe

- Pathway: 510(k) (Traditional)
- Applicant: Ninepoint Medical, Inc.
- Decided: Jul 19, 2019 after 84 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: 9 generations back to K895614 (1989). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182261: NvisionVLE Imaging System, NvisionVLE Optical Probe, Ninepoint Medical, Inc. (2018) Summary page 5.

## Indications for use
The Low-Profile Optical Probe, as part of the NvisionVLE Imaging System, is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal and pancreatico-biliary system tissue microstructures, by providing two-dimensional, cross-sectional, real-time depth visualization. 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/K191117
Methodology: https://510kreport.com/methodology