Product code PIB

Device name

Diabetic Retinopathy Detection Device

Medical specialty

Ophthalmic

Device class

2

Regulation number

886.1100

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

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.

Source

FDA openFDA device classification dataset