# DEN180001: IDx-DR

- Pathway: De Novo (Direct)
- Applicant: Idx, LLC
- Decided: Apr 11, 2018 after 89 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K203629: IDx-DR (2021), 2 descendants of its own
- K221183: Aeye-DS (2022), 1 descendant of its own
- K200667: EyeArt (2020), 1 descendant of its own
- K253704: iPredict-DR (2026), 0 descendants of its own
- K240058: Aeye-DS (2024), 0 descendants of its own

## Indications for use
IDx-DR 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. IDx-DR is indicated for use with the Topcon NW400.

Source page: https://510kreport.com/device/DEN180001
Methodology: https://510kreport.com/methodology