Siemens Healthcare Limited

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121277583012127758Siemens Healthcare Limited1N2026-01-011577 North Service Road East Oakville Ontario CA L6H 0H6

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2250031629963605P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE2011-02-11
2250031085343004P010025LORAD DIGITAL BREAST IMAGERMUE2002-03-15
2250031788792821K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorKPR2026-01-20
2250031180054690K202966SIGNA ArchitectLNH2020-11-13
2250031470573698K193028MEDRAD Mark 7 Arterion Injection SystemDXT2019-12-05
2250031001454668K162268Senographe PristinaMUE2016-11-03
2250031439983828K142955SOMATOM 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 PowerJAK2015-11-24
2250031398401399K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsIYN2014-10-23
2250031120649729K142383Optima XR200amx, Optima XR220amxIZL2014-09-25
2250031964921247K142361Discovery MR750 3.0TLNH2014-12-05
2250031119995136K133435MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13ALNH2013-12-12
2250031201009663K132094CIOS ALPHAOWB2014-03-11
2250031288247192K131885SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)MUE2013-09-26
2250031740308921K130842ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIESIZI2013-05-21
2250031973998463K123938SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYNLNH2013-02-12
2250031803152573K121072SOMATOM DEFINITION FLASHJAK2012-05-08
2250031426142124K120062DRX-REVOLUTION MOBILE X-RAY SYSTEMIZL2012-04-13
2250031160597007K091536OPTIMA MR450WLNH2009-07-17
2250031615005633K050456MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEMDXT2005-06-17
2250031791942973K042784MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEMDXT2004-12-10
2250031999798192K033881MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULEDXT2004-03-02
2250031424981769K033737ALLURA XPER FD20OWB2003-12-09
2250031571549835K032428MAGNETOM AVANTO MR SYSTEMLNH2003-10-16
2250031638567540K023183MEDRAD STELLANT CT INJECTOR SYSTEMDXT2003-01-10
2250031427719862

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LNH62020-11-13
DXT52019-12-05
MUE32016-11-03
JAK22015-11-24
IZL22014-09-25
OWB22014-03-11
KPR12026-01-20
IYN12014-10-23
IZI12013-05-21
OTE12011-02-11