Devices · IDx, LLC

IDx-DR

IDx, LLC is listed for IDx-DR (DEN180001). The FDA list gives April 11, 2018 as the date of the final decision. The lead panel is Ophthalmic, and the database link on the FDA list is the De Novo pathway. openFDA describes product code PIB as “Diabetic Retinopathy Detection Device”: 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. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN180001

Official FDA database record

Date of final decision

April 11, 2018

Company on the FDA list

IDx, LLC

Lead panel

Ophthalmic

Primary product code

PIB

openFDA device name for the code

Diabetic Retinopathy Detection Device

Device class

2

Regulation number

886.1100

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned