# K102599: Tomophase Octis

- Pathway: 510(k) (Traditional)
- Applicant: Tomophase Corporation
- Decided: Dec 1, 2010 after 82 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: 2 generations back to K944523 (1994). 2 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 13 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
- 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

## Indications for use
The Tomophase OCTIS (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/K102599
Methodology: https://510kreport.com/methodology