# K042894: Imalux Niris Imaging System

- Pathway: 510(k) (Special)
- Applicant: Imalux Corporation
- Decided: Nov 19, 2004 after 30 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: 2 generations back to K944523 (1994). 2 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 17 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.

## Most influential descendants
- K112770: Nvision Vle Imaging System, Nvision Vle Catheter (2011), 9 descendants of its own
- 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
- K160240: Perimeter Otis™ 1.0 Optical Coherence Tomography System (2016), 3 descendants of its own
- K171560: OTIS Optical Coherence Tomography System (2017), 2 descendants of its own

## Recalls of this device
- Dec 22, 2011 · Not classified · Z-0934-2012: During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit.

## Indications for use
The Imalux Niris 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/K042894
Methodology: https://510kreport.com/methodology