# K033783: Imalux Oct Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Imalux Coporation
- Decided: Mar 1, 2004 after 88 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: 1 generation back to K944523 (1994). 1 ancestor in all.
18 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944523: Humphrey Oct (Optical Coherence Tomography) Scanner, Humphrey, Inc. (1994) Summary page 1.

## Most influential descendants
- K042894: Imalux Niris Imaging System (2004), 14 descendants of its own
- K102599: Tomophase Octis (2010), 10 descendants of its own
- 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

## Indications for use
The Imalux OCT (Optical Coherence Tomography) 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/K033783
Methodology: https://510kreport.com/methodology