Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015418961

FEI Number

3015418961

Entity Name

RETIA MEDICAL SYSTEMS INC

City/State/Country

White Plains, NY, US

Establishment Address

333 Westchester Ave., White Plains, NY 10604, US

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Retia Medical Systems, Inc. (Owner Number: 10059978)

Owner / Operator Contact Address

333 Westchester Ave., White Plains, NY 10604, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181372

PMA Number

N/A

All Registered Proprietary Names

Argos

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2019-03-17

Official Correspondent

Tim Luddy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Retia Medical 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 3015418961. Last updated year: 2026. Please use registration number 3015418961 when referencing this establishment in official correspondence.