# K211715: RetinAI Discovery

- Pathway: 510(k) (Traditional)
- Applicant: Retinai Medical AG
- Decided: Apr 28, 2022 after 329 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: 11 generations back to K896095 (1990). 20 ancestors in all.
1 later device descends 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)
- K162039: OptosAdvance 4.0 Software, Optos Plc. (2017) Summary page 4.

## Most influential descendants
- K232088: Altris IMS (2023), 0 descendants of its own

## Indications for use
The RetinAl Discovery 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 and measurements of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.

Source page: https://510kreport.com/device/K211715
Methodology: https://510kreport.com/methodology