# K113696: Optos Advance

- Pathway: 510(k) (Traditional)
- Applicant: Optos Plc.
- Decided: May 25, 2012 after 161 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K896095 (1990). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090439: FORUM, Carl Zeiss Meditec, Inc. (2009) Summary page 1.

## Most influential descendants
- K162039: OptosAdvance 4.0 Software (2017), 2 descendants of its own
- K211715: RetinAI Discovery (2022), 1 descendant of its own
- K232088: Altris IMS (2023), 0 descendants of its own
- K141922: Iris Intelligent Retinal Imaging System (2015), 0 descendants of its own

## Indications for use
The Optos Advance Software is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems.

Source page: https://510kreport.com/device/K113696
Methodology: https://510kreport.com/methodology