# K133209: Foresee (4C) Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Photonics, Inc.
- Decided: Mar 17, 2014 after 151 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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.
- K093520: Vivosight Topical Oct System, Michelson Diagnostics, Ltd. (2010) Summary page 1.

## Most influential descendants
- K191804: TOMi Scope (2019), 0 descendants of its own

## Indications for use
The Foresee (4C) Imaging System is indicated for use as an imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.

Source page: https://510kreport.com/device/K133209
Methodology: https://510kreport.com/methodology