# K143678: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory

- Pathway: 510(k) (Special)
- Applicant: Ninepoint Medical, Inc.
- Decided: Feb 6, 2015 after 44 days
- Product code: NQQ (System, Imaging, Optical Coherence Tomography (Oct))
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K895614 (1989). 17 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120800: Nvision Vle Imaging System, Ninepoint Medical, Inc. (2013) Summary page 5.

## Most influential descendants
- K153479: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System (2016), 2 descendants of its own
- K182616: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (2018), 1 descendant of its own
- K182261: NvisionVLE Imaging System, NvisionVLE Optical Probe (2018), 1 descendant of its own
- K251730: LIA Console  (542-7) (2025), 0 descendants of its own
- K191117: NvisionVLE Low-profile Optical Probe (2019), 0 descendants of its own

## Recalls of this device
- Apr 11, 2018 · Class II · Z-1781-2018: Distal tips of the probes may detach from the probe shaft during use.

## Indications for use
The Nvision VLE 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/K143678
Methodology: https://510kreport.com/methodology