Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022435840

FEI Number

3022435840

Entity Name

Intelerad USA

City/State/Country

Raleigh, NC, US

Establishment Address

305 Church at N Hills St,, 6th Floor, Raleigh, NC 27609, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Intelerad Medical Systems Incorporated (Owner Number: 9040757)

Owner / Operator Contact Address

800, boul. de Maisonneuve Est, 14th floor, MONTREAL, CA-QC H2L 4L8, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192176

PMA Number

N/A

All Registered Proprietary Names

HealthView ECG Manager Doctors Review System IntelePACS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2021-11-24
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2000-03-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-04-06

Official Correspondent

Eric Llewelyn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Intelerad Medical Systems Incorporated

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9615916	INTELERAD MEDICAL SYSTEMS INCORPORATED	MONTREAL Quebec, CA
1626313	DIGISONICS, INC.	Raleigh, NC, US
3008012314	LUMEDX	Raleigh, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3013300026	BIOSENSE WEBSTER, INC.	Irvine, CA, US
3003084417	STEREOTAXIS, INC.	Saint Louis, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022435840. Last updated year: 2026. Please use registration number 3022435840 when referencing this establishment in official correspondence.