Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014579028

FEI Number

3014579028

Entity Name

Digital Diagnostics Inc.

City/State/Country

Coralville, IA, US

Establishment Address

210 5th Street, Suite 103, Coralville, IA 52241, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Digital Diagnostics Inc. (Owner Number: 10058009)

Owner / Operator Contact Address

210 5th Street, Suite 103, Coralville, IA 52241, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213037

PMA Number

N/A

All Registered Proprietary Names

LumineticsCore

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PIB	Diabetic Retinopathy Detection Device	Ophthalmic	Class 2	886.1100	2022-06-21

Official Correspondent

Luke Miller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Digital Diagnostics Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014579028. Last updated year: 2026. Please use registration number 3014579028 when referencing this establishment in official correspondence.