Device class
Class II
Regulation 886.1100
Total clearances
7
2020-08-03 → 2026-07-02
Definition
What is Diabetic Retinopathy Detection Device
A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.
Classification details
Medical specialty
Ophthalmic
Regulation number
886.1100
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Digital Diagnostics, Inc. |
2 |
0 |
2022-06-17 |
|
Aeye Health, Inc. |
2 |
0 |
2024-04-23 |
|
Eyenuk, Inc. |
2 |
0 |
2023-06-16 |
|
iHealthscreen, Inc. |
1 |
1 |
2026-07-02 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 0926F |
CPT
|
— |
Medium
|
Performance measure for diabetic retinopathy screening documentation |
| 92004 |
CPT
|
— |
Medium
|
Comprehensive eye exam with posterior segment evaluation for retinal disease screening |
| 92012 |
CPT
|
— |
Medium
|
Intermediate eye exam with focus on retinal imaging analysis |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-07-02 |
K253704 |
iHealthscreen, Inc.
|
iPredict-DR |
| 2024-04-23 |
K240058 |
Aeye Health, Inc.
|
AEYE-DS |
| 2023-06-16 |
K223357 |
Eyenuk, Inc.
|
EyeArt v2.2.0 |
| 2022-11-10 |
K221183 |
Aeye Health, Inc.
|
AEYE-DS |
| 2022-06-17 |
K213037 |
Digital Diagnostics, Inc.
|
IDx-DR v2.3 |
| 2021-06-10 |
K203629 |
Digital Diagnostics, Inc.
|
IDx-DR |
| 2020-08-03 |
K200667 |
Eyenuk, Inc.
|
EyeArt |