# K944523: Humphrey Oct (Optical Coherence Tomography) Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Humphrey, Inc.
- Decided: Dec 15, 1994 after 90 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- 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
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K033783: Imalux Oct Imaging System (2004), 18 descendants of its own
- 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

Source page: https://510kreport.com/device/K944523
Methodology: https://510kreport.com/methodology