# K223357: EyeArt v2.2.0

- Pathway: 510(k) (Traditional)
- Applicant: Eyenuk, Inc.
- Decided: Jun 16, 2023 after 226 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)
- K200667: EyeArt, Eyenuk, Inc. (2020) Summary page 4.

## Indications for use
EyeArt is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy and vision-threatening diabetic retinopathy (severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and/or diabetic macular edema) in eyes of adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. EyeArt is indicated for use with Canon CR-2 AF, Canon CR-2 Plus AF, and Topcon NW400 cameras.

Source page: https://510kreport.com/device/K223357
Methodology: https://510kreport.com/methodology