510(k) K203629
K203629 is an FDA 510(k) premarket notification submitted by Digital Diagnostics, Inc. for the device "IDx-DR". The FDA issued a decision of Substantially Equivalent on June 10, 2021. The device falls under product code PIB (Diabetic Retinopathy Detection Device), a Class II device regulated under 21 CFR 886.1100. Digital Diagnostics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2021
- Date Received
- December 11, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diabetic Retinopathy Detection Device
- Device Class
- Class II
- Regulation Number
- 886.1100
- Review Panel
- OP
- Submission Type
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.