# K153479: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

- Pathway: 510(k) (Traditional)
- Applicant: Ninepoint Medical, Inc.
- Decided: Feb 16, 2016 after 76 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: 18 generations back to K943450 (1995). 372 ancestors in all.
2 later devices descend 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)
- K143678: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory, Ninepoint Medical, Inc. (2015) Summary page 5.
- K100558: Quanta Diode Laser System, Quanta System Spa (2010) Summary page 5.
- K993951: Spot Endoscopic Marker, Chek-Med Systems (2000) Summary page 5.

## Most influential descendants
- K182616: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (2018), 1 descendant of its own
- 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, realtime depth visualization, and may be used to mark areas of tissue. The NvisionVLE Imaging System is intended to provide an image of the 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/K153479
Methodology: https://510kreport.com/methodology