Data / Medical devices / United States / Intelerad USA

Intelerad USA: FDA-registered device maker in Raleigh, NC, United States, 4 510(k) clearances

Name: Intelerad USA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Intelerad USA is registered with the FDA (registration 3022435840) in Raleigh, NC, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 2, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3022435840
Address: 305 Church at N Hills St, 6th Floor, Raleigh, NC, United States, 27609
Owner or operator: Intelerad Medical Systems Incorporated (9040757)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: March 20, 2000
Registered through: 2026
Brand names listed: CardioPACS, Doctors Review System, HealthView ECG Manager, InteleHeart, IntelePACS, WebPAX

Devices it lists

Device	Product code	Class	Role	Source
Computer, Diagnostic, Programmable	DQK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 2, 2020	K192176	IntelePACS	LLZ	Substantially Equivalent	Intelerad Medical Systems Incorporated	accessdata.fda.gov
August 17, 2016	K152949	WebPAX	LLZ	Substantially Equivalent	Heart Imaging Technologies, LLC	accessdata.fda.gov
December 20, 2012	K123466	HEALTHVIEW ECG MANAGER	DQK	Substantially Equivalent	Lumedx	accessdata.fda.gov
July 5, 2012	K120514	CARDIOPACS	LLZ	Substantially Equivalent	Lumedx	accessdata.fda.gov

Compare with other makers

Updated April 2, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.