Diabetic Retinopathy Detection Device

PIB · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1100

Classification

FDA Product Code: PIB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 886.1100
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 7
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown