Siemens Healthcare G M B H

FDA Filings

This page includes the latest FDA filings for Siemens Healthcare G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006894636
FEI Number3006894636
NameSiemens Healthcare GmbH
Owner & OperatorSiemens AG/Siemens Healthcare GmbH
Contact AddressHenkestrasse 127 --
Erlangen DE-NOTA 91052 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressCR Radiation Oncology (RO) Doris-Ruppenstein-Str. 4
Erlangen Bayern, 91052 DE
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device



Registration Number3011194542
FEI Number3011194542
NameSiemens Healthcare GmbH
Owner & OperatorSIEMENS HEALTHCARE DIAGNOSTICS INC.
Contact AddressSiemens Healthcare Diagnostics Inc. 500, GBC Drive
Newark DE 19702 US
Official Correspondent
  • Marilyn Waxberg
  • 1-484-9016348-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressAm Studio 1
Berlin Berlin, 12489 DE
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Siemens Healthcare GmbH
syngo Dynamics 2020-07-22
Siemens Healthcare GmbH
syngo Dynamics 2020-07-22
Siemens Healthcare GmbH
SOMATOM go.Open Pro 2020-07-22
Siemens Healthcare GmbH
syngo.via View&GO (Version VA20A) 2020-07-16
Siemens Healthcare GmbH
Artis zee floor MN 2020-07-02
Siemens Healthcare GmbH
SIREMOBIL Compact L 2020-07-02
Siemens Healthcare GmbH
Syngo.via View&GO2020-07-01
Siemens Healthcare GmbH
MAGNETOM Vida Fit 2020-03-31
Siemens Healthcare GmbH
MAGNETOM Lumina 2020-03-24
Siemens Healthcare GmbH
MAGNETOM Vida 2020-03-24
Siemens Healthcare GmbH
MAGNETOM Sola Fit 2020-03-12
Siemens Healthcare GmbH
MAGNETOM Altea 2020-03-12
Siemens Healthcare GmbH
MAGNETOM Sola 2020-03-05
Siemens Healthcare GmbH
syngo.MR Applications 2020-02-14
Siemens Healthcare GmbH
MAGNETOM Terra 2020-02-12
Siemens Healthcare GmbH
MAGNETOM Prisma 2020-02-07
Siemens Healthcare GmbH
MAGNETOM Prisma 2020-02-07
Siemens Healthcare GmbH
MAGNETOM Skyra 2020-02-07
Siemens Healthcare GmbH
MAGNETOM Skyra 2020-02-07
Siemens Healthcare GmbH
MAGNETOM Aera 2020-02-07
Siemens Healthcare GmbH
MAGNETOM Verio 2020-02-05
Siemens Healthcare GmbH
MAGNETOM Avanto 2020-02-05
Siemens Healthcare GmbH
MAGNETOM Avanto 2020-02-05
Siemens Healthcare GmbH
SOMATOM go.Sim 2020-02-04
Siemens Healthcare GmbH
syngo.Interventional 2020-01-21
Siemens Healthcare GmbH
ARTIS icono floor 2020-01-20
Siemens Healthcare GmbH
syngo Application Software 2020-01-20
Siemens Healthcare GmbH
ARTIS icono biplane 2020-01-20
Siemens Healthcare GmbH
syngo Dynamics 2019-12-20
Siemens Healthcare GmbH
SOMATOM X.cite 2019-12-19
Siemens Healthcare GmbH
syngo.via 2019-12-12
Siemens Healthcare GmbH
syngo.via 2019-12-12
Siemens Healthcare GmbH
Artis zeego 2019-11-14
Siemens Healthcare GmbH
Artis zee multi-purpose 2019-11-14
Siemens Healthcare GmbH
Artis zee biplane 2019-11-14
Siemens Healthcare GmbH
Artis zee ceiling 2019-11-14
Siemens Healthcare GmbH
Artis zee floor 2019-11-14
Siemens Healthcare GmbH
Artis Q.zen biplane 2019-11-14
Siemens Healthcare GmbH
Artis Q.zen ceiling 2019-11-14
Siemens Healthcare GmbH
Artis Q.zen floor 2019-11-14
Siemens Healthcare GmbH
Artis zeego 2019-11-14
Siemens Healthcare GmbH
Artis Q biplane 2019-11-14
Siemens Healthcare GmbH
Artis Q ceiling 2019-11-14
Siemens Healthcare GmbH
Artis Q floor 2019-11-14
Siemens Healthcare GmbH
Insight BD 2019-10-07
Siemens Healthcare GmbH
MOBILETT Elara Max 2019-10-07
Siemens Healthcare GmbH
syngo.via View&GO 2019-10-07
Siemens Healthcare GmbH
syngo.via 2019-10-07
Siemens Healthcare GmbH
syngo.via 2019-10-07
Siemens Healthcare GmbH
syngo.via 2019-10-07
Siemens Healthcare GmbH
syngo.via 2019-10-07
Siemens Healthcare GmbH
syngo.via 2019-10-07
Siemens Healthcare GmbH
syngo.via 2019-10-07
Siemens Healthcare GmbH
syngo.via 2019-10-07
Siemens Healthcare GmbH
syngo.via 2019-10-07
Siemens Healthcare GmbH
syngo.via 2019-10-07
Siemens Healthcare GmbH
syngo.via 2019-10-07
Siemens Healthcare GmbH
syngo.via 2019-10-07
Siemens Healthcare GmbH
Mobilett Mira Max 2019-10-07
Siemens Healthcare GmbH
Mobilett XP hybrid 2019-10-07
Siemens Healthcare GmbH
Mobilett XP 2019-10-07
Siemens Healthcare GmbH
syngo.via 2019-10-07
Siemens Healthcare GmbH
Syngo.via (Version VB40A)2019-05-16
Siemens Healthcare GmbH
syngo.plaza 2019-05-09
Siemens Healthcare GmbH
syngo Dynamics 2019-02-25
Siemens Healthcare GmbH
syngo Dynamics 2019-02-25
Siemens Healthcare GmbH
syngo Dynamics 2019-02-25
Siemens Healthcare GmbH
syngo Dynamics 2019-02-25
Siemens Healthcare GmbH
syngo X Workplace 2019-02-21
Siemens Healthcare GmbH
syngo X Workplace 2019-02-21
Siemens Healthcare GmbH
Cios Spin 2019-02-11
Siemens Healthcare GmbH
Cios Alpha 2019-02-11
Siemens Healthcare GmbH
Cios Alpha 2019-01-03
Siemens Healthcare GmbH
syngo Dynamics 2018-11-16
Siemens Healthcare GmbH
syngo Dynamics 2018-11-16
Siemens Healthcare GmbH
syngo Dynamics 2018-11-16
Siemens Healthcare GmbH
syngo Dynamics 2018-11-16
Siemens Healthcare GmbH
syngo Dynamics 2018-11-16
Siemens Healthcare GmbH
syngo Dynamics 2018-11-16
Siemens Healthcare GmbH
3D X-Ray Tube mount 2018-10-25
Siemens Healthcare GmbH
syngo Imaging 2018-09-24
Siemens Healthcare GmbH
syngo Imaging 2018-09-24
Siemens Healthcare GmbH
syngo Imaging 2018-09-24
Siemens Healthcare GmbH
syngo Imaging 2018-09-24
Siemens Healthcare GmbH
syngo Dynamics 2018-09-24
Siemens Healthcare GmbH
syngo Dynamics 2018-09-24
Siemens Healthcare GmbH
syngo Dynamics 2018-09-24
Siemens Healthcare GmbH
syngo Imaging 2018-09-24
Siemens Healthcare GmbH
syngo.via WebViewer 2018-09-24
Siemens Healthcare GmbH
syngo Dynamics 2018-09-24
Siemens Healthcare GmbH
syngo.via protoNeo 2018-09-24
Siemens Healthcare GmbH
syngo MultiModality Workplace 2018-09-24
Siemens Healthcare GmbH
syngo MultiModality Workplace 2018-09-24
Siemens Healthcare GmbH
syngo.via WebViewer 2018-09-24
Siemens Healthcare GmbH
syngo.plaza 2018-09-24
Siemens Healthcare GmbH
syngo.plaza 2018-09-24
Siemens Healthcare GmbH
syngo.plaza 2018-09-24
Siemens Healthcare GmbH
syngo.plaza 2018-09-24
Siemens Healthcare GmbH
syngo.via WebViewer 2018-09-24
Siemens Healthcare GmbH
syngo MultiModality Workplace 2018-09-24
Siemens Healthcare GmbH
syngo.plaza 2018-09-24
Siemens Healthcare GmbH
syngo.plaza 2018-09-24
Siemens Healthcare GmbH
Syngo.via View&GO (Version VA10A)2018-09-07
Siemens Healthcare GmbH
Syngo.plaza2018-04-25
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
syngo.CT Clinical Extensions2018-04-18
Siemens Healthcare GmbH
Syngo®.via ProtoNeo (Version VA20)2017-11-20
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
PRIMUS2017-06-21
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
ZXT RADIATION THER2017-06-21
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
ONCOR / PRIMUS Linac with ARIA OIS update2017-06-21
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
ARTISTE Solution with SYS_VC102017-06-21
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
ARTISTE Solution V4.32017-06-21
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
ARTISTE Solution, V4.22017-06-21
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
ARTISTE Solution with SYS_VB502017-06-21
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
ONCOR 160 MLC2017-06-21
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
syngo RTT Connect2017-06-21
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
COHERENCE RTT Connect2017-06-21
Siemens Healthcare GmbH
Syngo Dynamics Version VA302017-06-01
Siemens Healthcare GmbH
Syngo.CT Cardiac Planning2017-04-21
SIEMENS HEALTHCARE GMBH
Syngo®.via ProtoNeo (Version VA10A)2016-07-11
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
SYNGO RT INTERFACE2015-12-01
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
SYNGO RT INTERFACE2015-12-01
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
syngo VSim2015-10-01
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
syngo Dosimetrist V2.72011-04-28
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
KONRAD TREATMENT PLANNING SOFTWARE2009-11-06
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
ARTISTE2009-08-20
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
ARTISTE Solution2009-08-20
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
ONCOR Expression2006-07-05
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
550 TXT TREATMENT TABLE2006-06-22
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
SIEMENS IMFAST2006-06-22
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
OPTIFOCUS2006-06-22
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
MODULEAF2006-06-22
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
MICROMLC2006-06-22
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
3D MLC2006-06-22
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
PRIMUS FAMILY2006-06-22
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
ONCOR FAMILY2006-06-22
Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]
ONCOR Avant Garde2006-06-22
Siemens Healthcare GmbH [SIEMENS HEALTHCARE DIAGNOSTICS INC.]
UniPOC2000-02-07
Siemens Healthcare GmbH [SIEMENS HEALTHCARE DIAGNOSTICS INC.]
RAPIDComm2000-02-07
Siemens Healthcare GmbH [SIEMENS HEALTHCARE DIAGNOSTICS INC.]
POCcelerator2000-02-07
Siemens Healthcare GmbH [SIEMENS HEALTHCARE DIAGNOSTICS INC.]
CentraLink2000-02-07

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