# K121195: Nvision Vle Imaging System Nvision Vle Catheter

- Pathway: 510(k) (Special)
- Applicant: Ninepoint Medical, Inc.
- Decided: Jul 25, 2012 after 97 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: 6 generations back to K895614 (1989). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112770: Nvision Vle Imaging System, Nvision Vle Catheter, Ninepoint Medical, Inc. (2011) Summary page 1.

## 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/K121195
Methodology: https://510kreport.com/methodology