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Data / Medical devices / System, Image Processing, Radiological / Canada

FDA-registered makers of System, Image Processing, Radiological in Canada: 28 establishments

28 establishments in Canada are registered with the FDA to make System, Image Processing, Radiological (product code LLZ). 24 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device
System, Image Processing, Radiological
Product code
LLZ
Country
Canada

Makers of System, Image Processing, Radiological in Canada

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Change Healthcare Canada CompanyRICHMOND British Columbia, CanadaExporter to the US, Manufacturer, Repackager or relabeler16November 12, 20240140api.fda.gov
Agfa Healthcare Inc.WATERLOO Ontario, CanadaSpecification developer11July 3, 2017000api.fda.gov
Merge CanadaMississauga Ontario, CanadaSpecification developer10April 14, 2025000api.fda.gov
Circle Cardiovascular Imaging IncCalgary Alberta, CanadaManufacturer6December 7, 2023000api.fda.gov
Zimmer CasMontreal, Quebec, CanadaManufacturer4May 23, 2023000api.fda.gov
CD Newco Canada Inc.Calgary Alberta, CanadaComplaint file establishment, Manufacturer3October 18, 2017000api.fda.gov
Ramsoft, Inc.TORONTO Ontario, CanadaManufacturer3November 17, 2022000api.fda.gov
Synaptive Medical IncMississauga Ontario, CanadaManufacturer3March 9, 2018010api.fda.gov
Convergent Imaging SolutionsOttawa Ontario, CanadaManufacturer2September 1, 2023000api.fda.gov
Densitas Inc.Halifax Nova Scotia, CanadaManufacturer2February 19, 2020000api.fda.gov
Limbus AiToronto Ontario, CanadaComplaint file establishment, Manufacturer2April 7, 2023000api.fda.gov
ResolutionMD, Inc.CALGARY Alberta, CanadaManufacturer2July 21, 2026000api.fda.gov
Denti.ai Technology Inc.Toronto Ontario, CanadaManufacturer1November 22, 2022000api.fda.gov
Focal Healthcare Inc.Toronto Ontario, CanadaManufacturer1June 15, 2018000api.fda.gov
Halifax Biomedical Inc.Mabou Nova Scotia, CanadaManufacturer1March 6, 2014000api.fda.gov
Hyland Software Canada ULCToronto Ontario, CanadaManufacturer1June 12, 2015000api.fda.gov
Intelerad Medical Systems IncorporatedMONTREAL Quebec, CanadaManufacturer1April 2, 2020040api.fda.gov
Intellijoint Surgical Inc.Kitchener Ontario, CanadaComplaint file establishment, Manufacturer1November 12, 2021000api.fda.gov
International Medical Solutions Inc.Mississauga Ontario, CanadaExporter to the US, Manufacturer1October 29, 2020000api.fda.gov
Mach7 Technologies Canada Inc.Waterloo Ontario, CanadaManufacturer1February 6, 2018000api.fda.gov
Novadaq Technologies ULCBurnaby British Columbia, CanadaManufacturer1September 17, 2008000api.fda.gov
Realize Medical Inc.Ottawa Ontario, CanadaManufacturer1January 17, 2023000api.fda.gov
Synthesis Health Intelligence Inc.Maple Ridge British Columbia, CanadaComplaint file establishment, Manufacturer1August 8, 2024000api.fda.gov
Ventripoint Diagnostics Ltd.Toronto Ontario, CanadaComplaint file establishment, Manufacturer1October 16, 2019000api.fda.gov
A7 IntegrationGranby Quebec, CanadaContract manufacturer0000api.fda.gov
Imeka Solutions Inc.Sherbrooke Quebec, CanadaManufacturer0000api.fda.gov
Natus Medical Incorporated Dba Excel-Tech Ltd. (xltek)OAKVILLE Ontario, CanadaComplaint file establishment, Manufacturer0000api.fda.gov
Nse-AutomatechGranby Quebec, CanadaContract manufacturer0000api.fda.gov

Updated November 2, 2026. 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.