# K112770: Nvision Vle Imaging System, Nvision Vle Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ninepoint Medical, Inc.
- Decided: Dec 16, 2011 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: 5 generations back to K895614 (1989). 15 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033783: Imalux Oct Imaging System, Imalux Coporation (2004) Summary page 1.
- K042894: Imalux Niris Imaging System, Imalux Corporation (2004) Summary page 1.
- K041077: Imalux Oct Probe Guide, Imalux Corporation (2004) Summary page 1.
- K102599: Tomophase Octis, Tomophase Corporation (2010) Summary page 1.

## Most influential descendants
- K120800: Nvision Vle Imaging System (2013), 6 descendants of its own
- K143678: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory (2015), 5 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K112770
Methodology: https://510kreport.com/methodology