# K240058: Aeye-DS

- Pathway: 510(k) (Traditional)
- Applicant: Aeye Health, Inc.
- Decided: Apr 23, 2024 after 106 days
- Product code: PIB (Diabetic Retinopathy Detection Device)
- Device class: 2
- Regulation: 21 CFR 886.1100
- 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 DEN180001 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221183: Aeye-DS, Aeye Health, Inc. (2022) Summary page 5.

## Indications for use
The AEYE-DS is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. The AEYE-DS is indicated for use with the Topcon NW400 camera and the Optomed Aurora camera.

Source page: https://510kreport.com/device/K240058
Methodology: https://510kreport.com/methodology