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Data / Medical devices / Canada / Siemens Healthcare Limited

Siemens Healthcare Limited: FDA-registered device maker in Oakville Ontario, Canada, 21 510(k) clearances and 2 PMA approvals

Siemens Healthcare Limited is registered with the FDA (registration 3012127758) in Oakville Ontario, Canada. It lists 18 device types. The FDA files 21 510(k) clearances and 2 PMA approvals under its listings, the newest dated January 20, 2026. Registered through 2027. 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.

Get makers like this oneWatch Siemens Healthcare Limited
FDA registration number
3012127758
Address
1577 North Service Road East, Oakville Ontario, Canada, L6H 0H6
Owner or operator
SIEMENS MEDICAL SOLUTIONS USA, INC. (9002915)
Roles
Exporter to the US
First device listed
November 4, 2014
Registered through
2027
Brand names listed
ALLURA XPER FD20, Acuson S1000 Diagnostic Ultrasound System, Acuson S2000 Diagnostic Ultrasound System, Acuson S3000 Diagnostic Ultrasound System, Allura FD 20 Xper, BODY 18 MR COIL 3T, Carestream DRX-Compass X-ray System, Carestream DRX-Evolution Plus X-ray System and more

Devices it lists

DeviceProduct codeClassRoleSource
Assembly, Tube Housing, X-Ray, DiagnosticITY1Exporter to the USaccessdata.fda.gov
Catheter, Ultrasound, IntravascularOBJ2Exporter to the USaccessdata.fda.gov
Digital Breast TomosynthesisOTE3Exporter to the USaccessdata.fda.gov
Full Field Digital, System, X-Ray, MammographicMUE2Exporter to the USaccessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, MobileOXO2Exporter to the USaccessdata.fda.gov
Injector And Syringe, AngiographicDXT2Exporter to the USaccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Exporter to the USaccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Exporter 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
System, Nuclear Magnetic Resonance ImagingLNH2Exporter to the USaccessdata.fda.gov
System, Nuclear Magnetic Resonance SpectroscopicLNI2Exporter to the USaccessdata.fda.gov
System, X-Ray, AngiographicIZI2Exporter to the USaccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Exporter to the USaccessdata.fda.gov
System, X-Ray, MobileIZL2Exporter to the USaccessdata.fda.gov
System, X-Ray, StationaryKPR2Exporter to the USaccessdata.fda.gov
System, X-Ray, Tomography, ComputedJAK2Exporter 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
January 20, 2026K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorKPRSubstantially EquivalentCarestream Healthaccessdata.fda.gov
November 13, 2020K202966SIGNA ArchitectLNHSubstantially EquivalentGe Healthcare (Ge Medical Systems, LLC)accessdata.fda.gov
December 5, 2019K193028MEDRAD Mark 7 Arterion Injection SystemDXTSubstantially EquivalentBayer Medical Care, Inc.accessdata.fda.gov
November 3, 2016K162268Senographe PristinaMUESubstantially EquivalentGE Healthcareaccessdata.fda.gov
November 24, 2015K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope PowerJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
December 5, 2014K142361Discovery MR750 3.0TLNHSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
October 23, 2014K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
September 25, 2014K142383Optima XR200amx, Optima XR220amxIZLSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
March 11, 2014K132094CIOS ALPHAOWBSubstantially EquivalentSiemens Medi Cal Solutions, Inc.accessdata.fda.gov
December 12, 2013K133435MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13ALNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
September 26, 2013K131885SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)MUESubstantially EquivalentGE Medical Systems SCSaccessdata.fda.gov
May 21, 2013K130842ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIESIZISubstantially EquivalentPhilips Medical Systems Nederland B.V.accessdata.fda.gov
February 12, 2013K123938SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYNLNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
May 8, 2012K121072SOMATOM DEFINITION FLASHJAKSubstantially EquivalentSiemens Medical Systems, Inc.accessdata.fda.gov
July 17, 2009K091536OPTIMA MR450WLNHSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
June 17, 2005K050456MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEMDXTSubstantially EquivalentMedrad, Inc.accessdata.fda.gov
December 10, 2004K042784MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEMDXTSubstantially EquivalentMedrad, Inc.accessdata.fda.gov
March 2, 2004K033881MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULEDXTSubstantially EquivalentMedrad, Inc.accessdata.fda.gov
December 9, 2003K033737ALLURA XPER FD20OWBSubstantially EquivalentPhilips Medical Systems North America, Inc.accessdata.fda.gov
October 16, 2003K032428MAGNETOM AVANTO MR SYSTEMLNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
January 10, 2003K023183MEDRAD STELLANT CT INJECTOR SYSTEMDXTSubstantially EquivalentMedrad, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
February 11, 2011P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE10November 24, 2025accessdata.fda.gov
March 15, 2002P010025LORAD DIGITAL BREAST IMAGERMUE17November 16, 2010accessdata.fda.gov

Compare with other makers

Updated January 20, 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.