510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PIBClass II

Diabetic Retinopathy Detection Device

21 CFR 886.1100 / Ophthalmic
FDA source (opens on fda.gov)

PIB is the FDA product code for Diabetic Retinopathy Detection Device, a class II device type, regulated under 21 CFR 886.1100. FDA's definition for this code reads: "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". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PIB
Device name
Diabetic Retinopathy Detection Device
FDA 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.
Regulation
21 CFR 886.1100
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code PIB

By decision year
8 clearances under product code PIB with a decision year between 2018 and 2026, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PIB by decision year
YearClearances
20181
20201
20211
20222
20231
20241
20261

Applicants with the most clearances

Product code PIB
Applicants holding the most 510(k) clearances under product code PIB
ApplicantClearances
Aeye Health Inc.2
Digital Diagnostics Inc.2
Eyenuk2
Idx, LLC1
iHealthscreen, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code