510(k) K240058
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2024
- Date Received
- January 8, 2024
- 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.