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Data / Medical devices / Canada / Cce Canada Commercial Exchange Inc.

Cce Canada Commercial Exchange Inc.: FDA-registered device maker in MISSISSAUGA Ontario, Canada, 27 510(k) clearances

Cce Canada Commercial Exchange Inc. is registered with the FDA (registration 3003412859) in MISSISSAUGA Ontario, Canada. It lists 4 device types. The FDA files 27 510(k) clearances under its listings, the newest dated July 27, 2018. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Cce Canada Commercial Exchange Inc.
FDA registration number
3003412859
Address
2735 Matheson BLVD. E. Unit #3, MISSISSAUGA Ontario, Canada, L4W 4M8
Owner or operator
CCE CANADA COMMERCIAL EXCHANGE INC. (9105479)
Roles
Exporter to the US
First device listed
December 23, 2013
Registered through
2026
Brand names listed
CCE CANADA COMMERCIAL EXCHANGE INC, CCE Medical Equipment, HD11, Sonoscape Company Limited

Devices it lists

DeviceProduct codeClassRoleSource
System, Image Processing, RadiologicalLLZ2Exporter to the USaccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Exporter to the USaccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Exporter to the USaccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Exporter to the USaccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 27, 2018K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
August 9, 2017K171070WS80A Diagnostic Ultrasound SystemIYNSubstantially EquivalentSamsung Medison Co., Ltd.accessdata.fda.gov
June 6, 2017K170374SonoBook Series Diagnostic Ultrasound SystemIYNSubstantially EquivalentChison Medical Imaging Co., Ltd.accessdata.fda.gov
March 4, 2015K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemIYNSubstantially EquivalentZonare Medical Systems, Inc.accessdata.fda.gov
October 3, 2014K142466UGEO PT60A Diagnostic Ultrasound SystemIYNSubstantially EquivalentSamsung Medison Co., Ltd.accessdata.fda.gov
September 24, 2013K131937VOLUSON I/EIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
June 18, 2013K130499IU22 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
April 12, 2013K130119PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYNSubstantially EquivalentSonoscape Company Limitedaccessdata.fda.gov
September 21, 2012K122327VOLUSON E6/E8/E8EXPERT/E10IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
September 11, 2012K122387VOLUSON P6, VOLUSON P8IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
December 29, 2011K113690GE LOGIQ I, LOGIQ E AND VIVID EIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
September 16, 2011K112451S8 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentSonoscape Company Limitedaccessdata.fda.gov
August 29, 2011K112339ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentSamsung Medison Co., Ltd.accessdata.fda.gov
August 31, 2010K101878GE LOGIQ P5 MODEL H44662LDIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
November 20, 2009K093488ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEMIYOSubstantially EquivalentAloka Co., Ltd.accessdata.fda.gov
September 2, 2008K082374VIVID I AND VIVID QIYNSubstantially EquivalentGe Medical Systems Israel, Ultrasound, Ltd.accessdata.fda.gov
July 11, 2008K081802CX50 DIAGNOSTIC ULTRASOUND SYSTEMITXSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
October 29, 2007K072918MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00ITXSubstantially EquivalentToshibamedical Systems Corporationaccessdata.fda.gov
August 18, 2006K062247HD11 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
January 6, 2005K043535HD11 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
January 28, 2004K040060SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMSIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 21, 2003K032974GE LOGIQ 5 PRO OR EXPERTIYNSubstantially EquivalentGeneral Electric Co.accessdata.fda.gov
April 17, 2003K030934GE LOGIQ 9 MODEL 2375600IYNSubstantially EquivalentGe Medical Systems, Inc.accessdata.fda.gov
April 7, 2003K030949TITAN HIGH RESOLUTION ULTRASOUND SYSTEMIYNSubstantially EquivalentSonosite,Inc.accessdata.fda.gov
December 12, 2002K023957SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)IYNSubstantially EquivalentSonosite,Inc.accessdata.fda.gov
January 7, 2002K014191M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540IYNSubstantially EquivalentPhilips Medical Systemsaccessdata.fda.gov
February 21, 2001K010374SONOSITE HAND-CARRIED ULTRASOUND SYSTEMIYNSubstantially EquivalentSonosite,Inc.accessdata.fda.gov

Compare with other makers

Updated July 27, 2018. 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.