510(k) DEN180001

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.