510(k) DEN180001
DEN180001 is an FDA 510(k) premarket notification submitted by Idx, LLC for the device "IDx-DR". The FDA issued a decision of De Novo Granted on April 11, 2018. The device falls under product code PIB (Diabetic Retinopathy Detection Device), a Class II device regulated under 21 CFR 886.1100.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 11, 2018
- Date Received
- January 12, 2018
- Clearance Type
- Direct
- 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.