# K162039: OptosAdvance 4.0 Software

- Pathway: 510(k) (Traditional)
- Applicant: Optos Plc.
- Decided: Feb 8, 2017 after 201 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: 10 generations back to K896095 (1990). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113696: Optos Advance, Optos Plc. (2012) Summary page 5.
- K151952: Synergy ODM, Topcon Medical Systems, Inc. (2015) Summary page 5.

## Most influential descendants
- K211715: RetinAI Discovery (2022), 1 descendant of its own
- K232088: Altris IMS (2023), 0 descendants of its own

## Indications for use
OptosAdvance 4.0 is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, diagnostic data, clinical images and information, reports, videos, and measurement of DICOM-compliant images.

Source page: https://510kreport.com/device/K162039
Methodology: https://510kreport.com/methodology