FDA.report

Siemens Healthcare GmbH

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30111945423011194542Siemens Healthcare GmbH1N2026-01-01Am Studio 1 Berlin DE 12489
30068946363006894636Siemens Healthcare GmbH1N2020-04-25CR Radiation Oncology (RO) Doris-Ruppenstein-Str. 4 Erlangen Bayern DE 91052

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2090441253473812K993425PRIMUSIYE1999-11-26
2090441044985837K910971Z XT RADIATION THERAPY TREATMENT TABLEJAI1991-05-03
2090441023152409K173625syngo.CT Clinical ExtensionsJAK2018-03-08
2090441072418173K151887syngo VSimMUJ2015-09-16
2090441729145893K142434ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1IYE2014-11-21
2090441561295772K132935ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEMEIYE2014-02-21
2090441333039760K123812COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIVIYE2013-03-01
2090441880904867K121295ARTISTETM SOLUTION WITH SYS VCIOIYE2012-06-27
2090441063819568K120363SYNGO RT INTERFACEMUJ2012-03-20
2090441119151877K103606ARTISTE SOLUTION WITH SYS_VB50 UPDATEIYE2011-04-15
2090441902571817K101119SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864MUJ2010-06-16
2090441039983024K092145160MLC OPTIONIYE2009-09-18
2090441055241533K090683SYNGO RT THERAPIST CONNECTIYE2009-05-08
2090441718722257K072485ARTISTE MV SAIYE2007-12-27
2090441370436861K060226ONCOR EXPRESSIONIYE2006-03-15
2090441775206298K050422550 TXT TREATMENT TABLEJAI2005-03-18
2090441613110720K032790MICROMLCIXI2003-10-02
2090441955819722K031764ONCOR AVANT-GARDE WITH COHERENCE WORKSPACESIYE2003-09-05
2090441993362502K022307KONRAD, MODEL V.2.0MUJ2002-10-08
2098231376055993

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
IYE112014-11-21
MUJ42015-09-16
JAI22005-03-18
JAK12018-03-08
IXI12003-10-02

PMN

GUDID

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