Diabetic Retinopathy Detection Device
The Diabetic Retinopathy Detection Device is a prescription software device incorporating an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions, including diabetic retinopathy. It is an FDA Class 2 device regulated under 21 CFR 886.1100, requiring 510(k) premarket notification, within the Ophthalmic (OP) medical specialty. The product code is PIB. This device is not implantable and is not life-sustaining.
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Basic Information
- Product Code
- PIB
- Device Class
- FDA class 2
- Regulation Number
- 886.1100
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240058 | AEYE-DS | Apr 23, 2024 | Substantially Equivalent | Aeye Health, Inc. |
| K223357 | EyeArt v2.2.0 | Jun 16, 2023 | Substantially Equivalent | Eyenuk, Inc. |
| K221183 | AEYE-DS | Nov 10, 2022 | Substantially Equivalent | Aeye Health, Inc. |
| K213037 | IDx-DR v2.3 | Jun 17, 2022 | Substantially Equivalent | Digital Diagnostics, Inc. |
| K203629 | IDx-DR | Jun 10, 2021 | Substantially Equivalent | Digital Diagnostics, Inc. |
| K200667 | EyeArt | Aug 03, 2020 | Substantially Equivalent | Eyenuk, Inc. |
| DEN180001 | IDx-DR | Apr 11, 2018 | Unknown | Idx, LLC |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.