# K203629: IDx-DR

- Pathway: 510(k) (Traditional)
- Applicant: Digital Diagnostics, Inc.
- Decided: Jun 10, 2021 after 181 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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
- K253704: iPredict-DR (2026), 0 descendants of its own
- K213037: IDx-DR v2.3 (2022), 0 descendants of its own

## Indications for use
IDx-DR is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400.

Source page: https://510kreport.com/device/K203629
Methodology: https://510kreport.com/methodology