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Data / Medical devices / Canada / Canadian Imaging Services Inc.

Canadian Imaging Services Inc.: FDA-registered device maker in Edmonton Alberta, Canada, 3 510(k) clearances

Canadian Imaging Services Inc. is registered with the FDA (registration 3043048939) in Edmonton Alberta, Canada. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 6, 2010. Registered through 2026. 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.

FDA registration number
3043048939
Address
4708 164 Avenue NW, Edmonton Alberta, Canada, T5Y 0A5
Owner or operator
Canadian Imaging Services Inc. (10094695)
Roles
Exporter to the US
First device listed
February 21, 2026
Registered through
2026
Brand names listed
GE OEC 9900 Elite C-arm System, Hologic Dimensions 2D/3D Mammography System, Philips Veradius, Philips Veradius Mobile C-arm with Flat Detector (FD)

Devices it lists

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 6, 2010K100692DIGITAL SPOT MAMMOGRAPHY SYSTEMIZHSubstantially EquivalentHologic, Inc.accessdata.fda.gov
May 1, 2009K082781OEC 9900 ELITEOWBSubstantially EquivalentGe Healthcare Surgeryaccessdata.fda.gov
March 16, 2009K090590VERADIUS, MODEL 718-130OWBSubstantially EquivalentPhilips Medical Systems North America Co.accessdata.fda.gov

Compare with other makers

Updated April 6, 2010. 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.