# K200667: EyeArt

- Pathway: 510(k) (Traditional)
- Applicant: Eyenuk, Inc.
- Decided: Aug 3, 2020 after 143 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: 1 generation back to DEN180001 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180001: IDx-DR, Idx, LLC (2018) Summary page 4.

## Most influential descendants
- K223357: EyeArt v2.2.0 (2023), 0 descendants of its own

## 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 more than mild diabetic retinopathy. EyeArt is indicated for use with Canon CR-2 AF and Canon CR-2 Plus AF cameras in both primary care and eye care settings.

Source page: https://510kreport.com/device/K200667
Methodology: https://510kreport.com/methodology