FDA.reportPublic FDA data

SIEMENS MEDICAL SOLUTIONS USA, INC.

Matched from indexed company URL: Siemens Medical Solution

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10349731034973SIEMENS MEDICAL SOLUTIONS USA, INC.1N2026-01-01810 INNOVATION DR. KNOXVILLE TN US 37932
14232531000514697SIEMENS MEDICAL SOLUTIONS USA, INC.1N2026-01-012501 NORTH BARRINGTON RD. Hoffman Estates IL US 60192
18365493003304172SIEMENS MEDICAL SOLUTIONS USA, INC.1N2026-01-01400 W. MORGAN ROAD ANN ARBOR MI US 48108
22408692240869SIEMENS MEDICAL SOLUTIONS USA, INC.1Y2026-01-0140 Liberty Boulevard Malvern PA US 19355
25318143002626007Siemens Medical Solutions USA, Inc.1N2026-01-015168 Campus Dr. Plymouth Meeting PA US 19462
30232453023245SIEMENS MEDICAL SOLUTIONS USA, INC.1Y2026-01-0122010 S.E. 51ST ST. ISSAQUAH WA US 98029
30063657533006365753SIEMENS MEDICAL SOLUTIONS USA, INC.1N2020-04-25203 DUNAVANT DRIVE ROCKFORD TN US 37853
30068141093006814109Siemens Medical Solutions USA, Inc.1N2020-04-252500 Millbrook Dr. Suite B Buffalo Grove IL US 60089
30094985912936884Siemens Medical Solutions USA, Inc.1Y2020-04-25685 East Middlefield Road Mountain View CA US 94043

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04056869001210Symbia_Intevo_Excel - 10764801+1(800)888-7436XX@XX.XX
04056869001210Symbia_Intevo_Excel - 10764801+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1379441432016443K991805ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTIONIYN1999-08-02
1379441247820596K946179SIEMENS SONOLINE 4XXIYO1995-10-03
126181391809880K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 FamilyKPS2026-05-21
126181876345507K254016MI View&GOQIH2026-02-10
126161161025582K253689syngo Dynamics (VA41F)QIH2026-04-10
126301364014859K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound SystemIYN2025-11-17
126301115295580K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound SystemIYN2025-11-13
126171148537016K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsKPS2025-07-03
126181148537016K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsKPS2025-07-03
126171006478860K251561Biograph TrinionKPS2025-07-31
126181006478860K251561Biograph TrinionKPS2025-07-31
126181883454349K251528syngo.via MI Workflows; Scenium; syngo MBFQIH2025-07-03
126301772254102K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemIYN2025-08-20
126301421595643K243299ACUSON Redwood Diagnostic Ultrasound SystemIYN2024-11-15
126181437856988K243186Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A FamilyKPS2024-10-30
126161467394232K242551syngo Dynamics (Version VA41D)QIH2025-04-03
126301164816927K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemIYN2024-11-19
126181436889654K242300MI View&GOQIH2024-08-30
126181131589079K242275syngo.via MI Workflows; Scenium; syngo MBFQIH2024-08-30
126181021219647K241898Symbia SPECT and SPECT/CT SystemsKPS2024-07-26
126301518194669K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound SystemIYN2024-07-22
126171622801069K233677Biograph VK10KPS2024-01-12
126181622801069K233677Biograph VK10KPS2024-01-12
126301989968322K233613ACUSON SC2000 Diagnostic Ultrasound SystemIYO2024-06-12
126302019828918K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemIYN2024-06-12
126301438149075K233270AcuNav Crystal Ultrasound CatheterOBJ2023-10-28
126301808357657K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound SystemIYN2023-09-26
126301460171041K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound SystemIYN2023-10-30
126181362074112K232000syngo.via MI Workflows; Scenium; syngo MBFQIH2023-11-28
126171221246431K231833Biograph Vision.X and Biograph Vision.X EdgeKPS2023-07-13
126181221246431K231833Biograph Vision.X and Biograph Vision.X EdgeKPS2023-07-13
126181634544987K231102Symbia Pro.specta VA20A FamilyKPS2023-05-17
126301654039238K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound SystemIYN2023-02-13
126301123276282K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound SystemIYN2023-02-06
126171405635519K223547Biograph Vision Quadra PET/CT SystemKPS2022-12-22
126181405635519K223547Biograph Vision Quadra PET/CT SystemKPS2022-12-22
126161491591476K222428Syngo Dynamics (Version VA40F)QIH2022-11-14
126181786226816K222172MI View&GOQIH2022-08-19
126301971852586K221500ACUSON Sequoia Diagnostic Ultrasound SystemIYN2022-06-14
126301276141559K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound SystemIYN2022-08-16
126161793512379K220832syngo Dynamics (Version VA40E)LLZ2022-05-20
126301272589527K213487ACUSON P500 Ultrasound SystemIYN2022-02-11
126301972443696K212959ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) CatheterOBJ2021-10-15
126181845639865K212604Symbia VA10A FamilyKPS2021-09-16
126301669674294K211859ACUSON Sequoia Diagnostic Ultrasound SystemIYN2021-07-20
126301910045629K211726Acuson SC2000 Diagnostic Ultrasound SystemIYO2021-11-05
126181652944873K211459syngo.via MI WorkFlows, Scenium, syngo MBFQIH2021-06-10
126301359595568K210743ACUSON Redwood Diagnostic Ultrasound SystemIYN2021-04-01
126181849497256K210557Symbia VA10A FamilyKPS2021-05-12
126171138475950K210262Biograph Vision Quadra PET/CT SystemKPS2021-03-03
126181138475950K210262Biograph Vision Quadra PET/CT SystemKPS2021-03-03
126301084886042K203726ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) CatheterOBJ2021-01-19
126302064792953K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound SystemIYN2020-10-15
1511992064792953K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound SystemIYN2020-10-15
126301722524341K201462ACUSON Sequoia Diagnostic Ultrasound SystemIYN2020-06-24
126301992079978K201130ACUSON Juniper Diagnostic Ultrasound SystemIYN2020-05-26
126301265423820K200707ACUSON Sequoia Diagnostic Ultrasound SystemIYN2020-04-15
1379441265423820K200707ACUSON Sequoia Diagnostic Ultrasound SystemIYN2020-04-15
126301942834495K200644ACUSON Freestyle Diagnostic Ultrasound SystemIYN2020-04-10
1379441942834495K200644ACUSON Freestyle Diagnostic Ultrasound SystemIYN2020-04-10
1511991942834495K200644ACUSON Freestyle Diagnostic Ultrasound SystemIYN2020-04-10
126301909159032K200585Acuson SC2000 Diagnostic Ultrasound SystemIYN2020-04-22
126181127299025K200474Symbia 6.7KPS2020-03-20
126301033825396K193257ACUSON Sequoia Diagnostic Ultrasound SystemIYN2020-01-31
1379441033825396K193257ACUSON Sequoia Diagnostic Ultrasound SystemIYN2020-01-31
126141871735948K193248Biograph Vision, Biograph mCT Family of PET/CTsKPS2020-02-14
126171871735948K193248Biograph Vision, Biograph mCT Family of PET/CTsKPS2020-02-14
126181871735948K193248Biograph Vision, Biograph mCT Family of PET/CTsKPS2020-02-14
126141775888263K193178Biograph HorizonKPS2020-02-12
126171775888263K193178Biograph HorizonKPS2020-02-12
126181775888263K193178Biograph HorizonKPS2020-02-12
126301376852748K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemIYN2019-10-22
783861376852748K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemIYN2019-10-22
1379441376852748K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemIYN2019-10-22
126301406031990K192085
783861406031990K192085
1379441406031990K192085
126301609564133K191922ACUSON P200 Diagnostic Ultrasound SystemIYN2019-08-15
1379441609564133K191922ACUSON P200 Diagnostic Ultrasound SystemIYN2019-08-15
126181072889996K191309syngo.via MI Workflows VB40A, SceniumLLZ2019-07-19
126141395969117K190900Biograph VisionKPS2019-05-06
126171395969117K190900Biograph VisionKPS2019-05-06
126181395969117K190900Biograph VisionKPS2019-05-06
126301641241512K181098ACUSON SC2000 Diagnostic Ultrasound SystemIYN2018-05-31
783861641241512K181098ACUSON SC2000 Diagnostic Ultrasound SystemIYN2018-05-31
1379441641241512K181098ACUSON SC2000 Diagnostic Ultrasound SystemIYN2018-05-31
126141326895745K180811Biograph VisionKPS2018-05-23
126171326895745K180811Biograph VisionKPS2018-05-23
126181326895745K180811Biograph VisionKPS2018-05-23
126301067673579K180067ACUSON X800 Diagnostic Ultrasound SystemIYN2018-02-07
1379441067673579K180067ACUSON X800 Diagnostic Ultrasound SystemIYN2018-02-07
126301245278162K180039ACUSON P600 Diagnostic Ultrasound SystemIYN2018-02-01
1379441245278162K180039ACUSON P600 Diagnostic Ultrasound SystemIYN2018-02-01
126301500667144K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemIYN2018-02-02
1379441500667144K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemIYN2018-02-02
783861718433479K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemIYN2018-02-01
1379441718433479K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemIYN2018-02-01
126181518151613K173897syngo.via MI WorkflowsLLZ2018-04-05
126301352221985K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterOBJ2017-12-19
1379441352221985K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterOBJ2017-12-19
126181484973127K173597Scenium VE20 SoftwareLLZ2018-04-04
126141739637492K173578Biograph mCT Family of PET/CT SystemsKPS2017-12-20
126171739637492K173578Biograph mCT Family of PET/CT SystemsKPS2017-12-20
126181739637492K173578Biograph mCT Family of PET/CT SystemsKPS2017-12-20
1379441879359727K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemIYN2017-08-15
126301895914409K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsIYN2017-08-16
783861895914409K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsIYN2017-08-16
1379441895914409K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsIYN2017-08-16
783861585852692K171766Acuson SC2000 Diagnostic Ultrasound SystemIYO2017-07-12
1379441585852692K171766Acuson SC2000 Diagnostic Ultrasound SystemIYO2017-07-12
126161780914472K171053syngo Dynamics Version VA30LLZ2017-06-01
126301483312683K170992AcuNav V 10F Ultrasound CatheterOBJ2017-06-15
1379441483312683K170992AcuNav V 10F Ultrasound CatheterOBJ2017-06-15
126141990483512K170904Biograph Horizon PET/CTKPS2017-06-01
126171990483512K170904Biograph Horizon PET/CTKPS2017-06-01
126181990483512K170904Biograph Horizon PET/CTKPS2017-06-01
1379441226304231K170315Acuson SC2000 Diagnostic Ultrasound SystemIYN2017-04-04
126301110679234K170263AcuNav Diagnostic Ultrasound Catheter 8F,10FOBJ2017-06-15
1379441110679234K170263AcuNav Diagnostic Ultrasound Catheter 8F,10FOBJ2017-06-15
783862044106893K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsIYN2017-01-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN1622025-11-17
KPS632026-05-21
LLZ362022-05-20
IYO192024-06-12
OBJ142023-10-28
QIH102026-04-10
ITX42007-11-13
DQO12009-02-19

PMA#

IMMULITE® /IMMULITE® 1000 Free PSA and IMMULITE® 2000 Free PSA

2022-10-14

SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITEDglyn Rhonwy. Llanberiscaernarfongwynedd, Ll55 4EL PMA NumberP060005 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code MTG  Advisory Committee Immunology Supplement Type30-day Noti...

IMMULITE / IMMULITE 1000 Free PSA, IMMULITE 2000 Free PSA

2022-03-29

SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITEDglyn Rhonwy. Llanberiscaernarfongwynedd, Ll55 4EL PMA NumberP060005 Supplement NumberS014 Date Received02/28/2022 Decision Date03/29/2022 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reas...

PMN#

MI View&GO

2024-08-30

Siemens Medical Solutions USA, Inc.

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next