Data / Medical devices / Canada / Merge Canada

Merge Canada: FDA-registered device maker in Mississauga Ontario, Canada, 10 510(k) clearances

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

Merge Canada is registered with the FDA (registration 3032014234) in Mississauga Ontario, Canada. It lists 1 device type. The FDA files 10 510(k) clearances under its listings, the newest dated April 14, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Merge Canada

FDA registration number: 3032014234
Address: 2680 Skymark Avenue Suite Fl 2, Mississauga Ontario, Canada, L4W 5L6
Owner or operator: Merge Healthcare (10024020)
Roles: Specification developer
First device listed: June 22, 2010
Registered through: 2026
Brand names listed: CADstream, IBM iConnect Access, Merge Cardio, Merge OrthoPACS, Merge PACS, Merge Universal Viewer, iConnect Access

Devices it lists

Device	Product code	Class	Role	Source
System, Image Processing, Radiological	LLZ	2	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 14, 2025	K250301	Merge Universal Viewer (MUV)	LLZ	Substantially Equivalent	Merge Healthcare Incorporated	accessdata.fda.gov
January 26, 2021	K203104	IBM iConnect Access	LLZ	Substantially Equivalent	Merge Healthcare Incorporated	accessdata.fda.gov
October 17, 2019	K192455	Merge PACS	LLZ	Substantially Equivalent	Merge Healthcare Incorporated	accessdata.fda.gov
September 20, 2019	K192276	Merge Cardio	LLZ	Substantially Equivalent	Merge Healthcare Incorporated	accessdata.fda.gov
September 25, 2018	K182290	IBM iConnect Access	LLZ	Substantially Equivalent	Merge Healthcare Incorporated	accessdata.fda.gov
December 8, 2017	K173475	Merge PACS	LLZ	Substantially Equivalent	Merge Healthcare Incorporated	accessdata.fda.gov
June 23, 2010	K092915	CEDARA WEBACCESS, MODEL: 2.4	LLZ	Substantially Equivalent	Cedara Software Corp.	accessdata.fda.gov
November 6, 2009	K092954	CADSTREAM VERSION 5	LLZ	Substantially Equivalent	Confirma, Inc.	accessdata.fda.gov
September 5, 2008	K082144	AMICAS PACS, VERSION 6.0	LLZ	Substantially Equivalent	Amicas, Inc.	accessdata.fda.gov
August 2, 2005	K051649	VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0	LLZ	Substantially Equivalent	Camtronics Medical Systems	accessdata.fda.gov

Compare with other makers

All makers of System, Image Processing, Radiological

Updated April 14, 2025. 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.