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
MAGNETOM Viato.Mobile 2024-07-01
Siemens Healthcare GmbH
SOMATOM Pro.Pulse 2024-06-18
Siemens Healthcare GmbH
Syngo Carbon Enterprise Access 2024-06-11
Siemens Healthcare GmbH
CIARTIC Move 2024-05-09
Siemens Healthcare GmbH
MAMMOMAT B.brilliant 2024-04-29
Siemens Healthcare GmbH
AI-Rad Companion (Pulmonary) 2024-04-15
Siemens Healthcare GmbH
AI-Rad Companion (Pulmonary) 2024-04-09
Siemens Healthcare GmbH
MAGNETOM Terra.X Upgrade 2024-04-03
Siemens Healthcare GmbH
MAGNETOM Terra.X 2024-04-03
Siemens Healthcare GmbH
MAGNETOM Cima.X Fit 2024-03-13
Siemens Healthcare GmbH
syngo Virtual Cockpit 2024-01-24
Siemens Healthcare GmbH
Syngo Carbon Clinicals 2024-01-11
Siemens Healthcare GmbH
syngo Application Software 2024-01-09
Siemens Healthcare GmbH
MAGNETOM Cima.X 2023-12-29
Siemens Healthcare GmbH
MAGNETOM Cima.X 2023-12-29
Siemens Healthcare GmbH
syngo.CT Dual Energy 2023-12-27
Siemens Healthcare GmbH
syngo.CT Dual Energy 2023-12-26
Siemens Healthcare GmbH
syngo Carbon Space 2023-12-04
Siemens Healthcare GmbH
AI-Rad Companion Brain MR 2023-11-29
Siemens Healthcare GmbH
Upgrade Kit XA60A 2023-11-14
Siemens Healthcare GmbH
Chondral Quant 2023-07-25
Siemens Healthcare GmbH
syngo Carbon Space 2023-07-06
Siemens Healthcare GmbH
syngo.MR Applications 2023-03-27
Siemens Healthcare GmbH
syngo Dynamics 2023-03-24
Siemens Healthcare GmbH
syngo.via View&GO 2023-03-20
Siemens Healthcare GmbH
AI-Rad Companion (Cardiovascular) 2023-03-20
Siemens Healthcare GmbH
syngo.via View&GO 2023-03-20
Siemens Healthcare GmbH
syngo Dynamics 2023-03-17
Siemens Healthcare GmbH
syngo Dynamics 2023-03-17
Siemens Healthcare GmbH
syngo.CT Brain Hemorrhage 2022-12-08
Siemens Healthcare GmbH
MAGNETOM Avanto Fit 2022-12-07
Siemens Healthcare GmbH
AI-Rad Companion Organs RT 2022-11-17
Siemens Healthcare GmbH
syngo.CT Applications 2022-11-02
Siemens Healthcare GmbH
syngo.via RT Image Suite 2022-11-02
Siemens Healthcare GmbH
syngo.CT Extended Functionality 2022-11-02
Siemens Healthcare GmbH
syngo Application Software 2022-10-18
Siemens Healthcare GmBH
Syngo.via View&GO2022-10-14
Siemens Healthcare GmbH
ARTIS icono ceiling 2022-10-10
Siemens Healthcare GmbH
AI-Rad Companion (Pulmonary) 2022-10-06
Siemens Healthcare GmBh
AI-Rad Companion (Pulmonary)2022-08-11
Siemens Healthcare GmbH
AI-Rad Companion Brain MR 2022-06-10
Siemens Healthcare GmbH
MAGNETOM Skyra Fit 2022-05-27
Siemens Healthcare GmBh
AI-Rad Companion Brain MR2022-04-15
Siemens Healthcare GmbH
MAMMOVISTA B.smart 2022-02-18
Siemens Healthcare GmbH
syngo.MR Applications 2022-01-27
Siemens Healthcare GmbH
syngo.via 2022-01-24
Siemens Healthcare GmbH
MAMMOVISTA B.smart 2021-12-22
Siemens Healthcare GmbH
syngo Dynamics VA20G Packaging Label 2021-11-17
Siemens Healthcare GmbH
syngo Dynamics VA20G 2021-11-17
Siemens Healthcare GmbH
NAEOTOM Alpha 2021-10-21
Siemens Healthcare GmbH
syngo.via RT Image Suite 2021-09-29
Siemens Healthcare GmbH
syngo.CT Extended Functionality 2021-09-29
Siemens Healthcare GmbH
SOMATOM X.ceed 2021-09-28
Siemens Healthcare GmbH
syngo.CT Skull Unfolding 2021-09-13
Siemens Healthcare GmbH
AI-Rad Companion Organs RT 2021-08-16
Siemens Healthcare GmbH
Ai-Rad Companion Prostate MR 2021-08-16
Siemens Healthcare GmbH
AI-Rad Companion Brain MR 2021-08-16
Siemens Healthcare GmbH
Contour S Coil Set 2021-08-10
Siemens Healthcare GmbH
Contour S Coil 2021-08-10
Siemens Healthcare GmbH
BM Contour L Coil 2021-08-10
Siemens Healthcare GmbH
BM Contour L Coil set 0.55T 2021-08-10
Siemens Healthcare GmbH
UltraFlex Large 18 2021-08-09
Siemens Healthcare GmbH
UltraFlex Small 18 2021-08-09
Siemens Healthcare GmbH
UltraFlex Large 18 Coil Set 1.5T 2021-08-09
Siemens Healthcare GmbH
UltraFlex Small 18 Coil Set 1.5T 2021-08-09
Siemens Healthcare GmbH
MAGNETOM Vida 2021-07-19
Siemens Healthcare GmbH
MAGNETOM Lumina 2021-07-19
Siemens Healthcare GmbH
MAGNETOM Altea 2021-07-19
Siemens Healthcare GmbH
MAGNETOM Sola 2021-07-19
Siemens Healthcare GmbH
SOMATOM On.site 2021-05-27
Siemens Healthcare GmbH
Syngo.CT Lung CAD2021-03-31
Siemens Healthcare GmbH
AI-Rad Companion (Cardiovascular) 2021-03-17
Siemens Healthcare GmbH
AI-Rad Companion (Engine) 2021-03-17
Siemens Healthcare GmbH
AI-Rad Companion (Musculoskeletal) 2021-03-16
Siemens Healthcare GmbH
AI-Rad Companion (Pulmonary) 2021-03-16
Siemens Healthcare GmbH
AI-Rad Companion Organs RT 2021-02-26
Siemens Healthcare GmbH
AI-Rad Companion Prostate MR 2021-02-26
Siemens Healthcare GmbH
AI-Rad Companion Engine 2021-02-11
Siemens Healthcare GmbH
Cios Flow 2021-02-09
Siemens Healthcare GmbH
AI-Rad Companion Brain MR 2020-12-18
Siemens Healthcare GmbH
LUMINOS Lotus Max 2020-11-09
Siemens Healthcare GmbH
YSIO X.pree 2020-11-09
Siemens Healthcare GmbH
syngo Dynamics 2020-11-06
Siemens Healthcare GmbH
syngo Dynamics 2020-11-06
Siemens Healthcare GmbH
syngo.via 2020-10-08
Siemens Healthcare GmbH
SOMATOM go.Top 2020-09-07
Siemens Healthcare GmbH
SOMATOM go.All 2020-09-07
Siemens Healthcare GmbH
SOMATOM go.Up 2020-09-07
Siemens Healthcare GmbH
SOMATOM go.Now 2020-09-07
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 Aera 2020-02-07
Siemens Healthcare GmbH
Syngo.via (Version VB40A)2019-05-16
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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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092947094Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyELECTRICAL APPLIANCES LOW VOLTAGE MOTOR HS CODE 853225, 853669, 853890, 850450, 853321, 854110, 853400 HBL BANQBRE44528602 PKG
2020092377035Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaARTIS Q FLOOR HSC:902214009 CAS
2020092377035Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaARTIS Q FLOOR HSC:902214009 CAS
2020092377035Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaARTIS Q FLOOR HSC:902214009 CAS
2020092377035Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaARTIS Q FLOOR HSC:902214009 CAS
2020092377035Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaARTIS Q FLOOR HSC:902214009 CAS
2020092377035Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaARTIS Q FLOOR HSC:902214009 CAS
2020092377035Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaARTIS Q FLOOR HSC:902214009 CAS
2020092377035Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaARTIS Q FLOOR HSC:902214009 CAS
2020092377035Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaARTIS Q FLOOR HSC:902214009 CAS
2020092375271Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT,ARTIS Q CEILING LITHIUM ION BATTERIES16 PKG
2020092343971Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyELECTRICAL APPLIANCES LOW VOLTAGE MOTOR HS CODE 853225, 853669, 853890, 850450, 853321, 854110, 853400 HBL BANQBRE44528602 PKG
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091965553Bremerhaven,Federal Republic of Germany -> Houston, TexasARTIS PHENO KMAT HSC: 9022140016 CAS
2020091792825Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey12 PACKAGES MEDICAL EQUIPMENT HS-CODE:90221412 PKG
2020091792826Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT HS 90221420 PKG
2020091669932Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaSOMATOM PERSPECTIVE HSC: 902212004 CAS
2020091669932Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaSOMATOM PERSPECTIVE HSC: 902212004 CAS
2020091669932Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaSOMATOM PERSPECTIVE HSC: 902212004 CAS
2020091669932Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaSOMATOM PERSPECTIVE HSC: 902212004 CAS

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