FDA.reportPublic FDA data

De Novo DEN180001

Device
IDx-DR
Contact
michael d. abramoff
De Novo number
DEN180001
Product code
PIB
Regulation
886.1100
Classification name
diabetic retinopathy detection device
Decision
granted (DENG)
Decision date
2018-04-11
Date received
2018-01-12
Classification advisory
Ophthalmic
Review advisory
Ophthalmic
Type
Direct

Current FDA Classification#

Product code
PIB
Device name
Diabetic Retinopathy Detection Device
Medical specialty
Ophthalmic
Device class
2
Regulation
886.1100
Implant
N
Life sustain/support
N