Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011520729

FEI Number

3011520729

Entity Name

INTELLIGENT RETINAL IMAGING SYSTEMS, INC.

City/State/Country

Pensacola, FL, US

Establishment Address

2 North Palafox, Suite 200, Pensacola, FL 32502, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Intelligent Retinal Imaging Systems, Inc. (Owner Number: 10048903)

Owner / Operator Contact Address

2 N Palafox ste 200, Pensacola, FL 32502, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141922

PMA Number

N/A

All Registered Proprietary Names

VELARA Integration Software

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NFJ	System, Image Management, Ophthalmic	Radiology	Class 2	892.2050	2015-03-18

Official Correspondent

Annette Ramsey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Intelligent Retinal Imaging Systems, 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 3011520729. Last updated year: 2026. Please use registration number 3011520729 when referencing this establishment in official correspondence.