FDA.reportPublic FDA data

Siemens Healthineers AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30024660183002466018Siemens Healthineers AG1N2027-01-01ROENTGENSTRASSE 19-21 KEMNATH Bavaria DE 95478
30028081573002808157Siemens Healthineers AG1N2027-01-01Allee am Rothelheimpark 2 ERLANGEN Bavaria DE 91052
30049773353004977335Siemens Healthineers AG1N2027-01-01SIEMENSSTRASSE 1 -OR- Rittigfeld 1 FORCHHEIM Bavaria DE 91301

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
04068151034202syngo Dynamics - 11708404+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM
04068151086584LungMaps - Magnetic Resonance (MR) Systems – Medical Device Software+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM
04068151994995SOMATOM X.cite - 11330001+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM
04068151995008System SOMATOM X.ceed - 11330002+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM
04068151995114MAGNETOM Altea - MRI Scanner+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM
04068151995121MAGNETOM Altea - MRI Scanner+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
88761749934006P140011MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTIONOTE2015-04-21
88801133286350K994315CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEMMOS2000-02-04
88801924246403K993731SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEMLNH1999-12-23
88761772811212K992925AX WORKSTATION DR-VIEWER SOFTWARE OPTIONLLZ1999-11-23
88761310799481K992073AX WORKSTATIONLLZ1999-09-09
88761443208410K991922DIGITAL IMAGING SYSTEM (BSR)IZI1999-09-01
88801649635435K991319RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALSIYE1999-09-21
88761528058304K990426CALCIUM SCORINGJAK1999-05-12
88761653469149K9846343D-ANGIOJAK1999-03-12
88802048253204K984221FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MRLNH1999-02-12
88801427782036K983327ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMSLNH1998-10-09
88761214163541K982536PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGEJAK1998-11-24
88761548900779K982028FLUOROSPOT COMPACTJAA1998-07-14
88801782563255K973630CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEMMOS1997-12-05
88801607036004K971684MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)LNH1997-08-05
88761829905282K971452MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLEIZZ1997-05-14
88761275874229K971054OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMSJAK1997-06-13
88761365871570K963093SIREMOBIL COMPACTOXO1996-09-03
88801726753590K962627CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEMLNI1997-04-03
88761854883343K960635PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMSJAK1996-04-03
88801430150397K951006KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)IXA1995-04-03
88761430150397K951006KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)IXA1995-04-03
88761296182249K945293TOP ACOM STATIONIZI1995-01-05
88801685628060K935752CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILSLNH1994-03-29
88761891379514K932672MAMMOMAT 300 AND MAMMOMAT 3000IZH1994-09-14
88801398433990K932271MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016LNH1994-01-07
88751082830297K781984COLLIMATOR, HEART CONTOURKPW1978-12-04
88801918006855K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH2026-07-31
88801304360177K260758MAGNETOM Free.Max; MAGNETOM Free.StarLNH2026-09-01
88801962914645K260265MAGNETOM Flow.Ace; MAGNETOM Flow.PlusLNH2026-02-23
88761408143376K260055syngo.CT Brain QuantificationQIH2026-09-25
88761354511525K254184syngo Application SoftwareQIH2026-04-29
88761727155931K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB2026-04-24
88761365564690K253786syngo.CT Coronary CockpitQIH2026-06-25
88761407732232K253752ARTIS genio floor; ARTIS icono.explore floorOWB2026-04-23
88801037634694K253690LungMapsQIH2026-06-15
88761492158219K253678MAMMOMAT B.brilliant (11372950)MUE2026-06-18
88761030827994K253574SOMATOM X.cite; SOMATOM X.ceedJAK2026-03-20
88761747129426K253495syngo.MR Applications (VB80)LLZ2025-11-20
88801779147569K253057AI-Rad Companion Brain MRQIH2026-01-22
88801359420539K253023BIOGRAPH OneOUO2026-01-15
88801475600509K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseLNH2025-12-19
88801418100217K252608AI-Rad Companion Prostate MRLLZ2025-09-09
88801135384649K252548AI-Rad Companion Organs RTQKB2026-04-10
88801077874341K251822MAGNETOM Free.Max; MAGNETOM Free.StarLNH2025-11-20
88761568097465K251805syngo.CT Dual EnergyJAK2025-10-15
88761143541106K251523Cios SpinOWB2025-07-29
88761506916624K251520Cios Alpha; Cios FlowOWB2025-07-09
88761182299978K251061NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeJAK2025-07-28
88761339958495K251059Syngo Carbon Clinicals (VA41)QIH2025-10-24
88761408539112K250822SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.PulseJAK2025-07-03
88761556203295K250738YSIO X.preeKPR2025-07-31
88761064931734K250660LUMINOS Q.namix T; LUMINOS Q.namix ROWB2025-07-14
88801286544825K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileLNH2025-06-16
88801934556876K250436MAGNETOM Flow.Ace; MAGNETOM Flow.PlusLNH2025-06-16
88761931041097K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeJAK2025-02-12
88761247467457K243145syngo.CT LVO DetectionQAS2025-04-10
88801835622718K242745AI-Rad Companion Organs RTQKB2025-03-27
88801674882366K242551syngo Dynamics (Version VA41D)QIH2025-04-03
88761809434036K241757syngo.CT Dual EnergyJAK2025-01-03
88762000361693K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)OWB2024-10-22
88761265402701K241569syngo Application SoftwareLLZ2024-10-11
88761853493065K241295SOMATOM On.siteJAK2024-09-03
88801543774918K240608MAGNETOM Viato.MobileLNH2024-03-29
88761737221007K240294Syngo Carbon Enterprise Access (VA40A)LLZ2024-05-23
88801787127599K233753AI-Rad Companion (Pulmonary)JAK2024-03-21
88761678273213K233748CIARTIC Move (VB10)OWB2024-03-15
88761427413957K233657NAEOTOM AlphaJAK2024-03-28
88761170526621K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceedJAK2024-03-26
88761867739675K233543YSIO X.preeKPR2024-05-21
88761790457330K233539MAMMOMAT B.brilliantMUE2024-03-27
88761047844014K232976VUZE SystemLLZ2024-05-09
88801320255803K232899AI-Rad Companion Organs RTQKB2024-04-03
88761094638133K232856Syngo Carbon ClinicalsQIH2023-12-01
88761755647550K232799syngo.via RT Image SuiteMUJ2024-04-26
88801840508341K232765MAGNETOM Cima.X FitLNH2024-02-29
88762033622702K232744syngo Virtual Cockpit (VB10A)LLZ2023-12-21
88801341964351K232535MAGNETOM Sola; MAGNETOM AlteaLNH2023-12-22
88801309801189K232494MAGNETOM Avanto fit; MAGNETOM Skyra fitLNH2023-11-14
88801500048612K232482MAGNETOM Viato.MobileLNH2023-09-06
88761569552220K232431syngo.CT Brain HemorrhageQAS2024-03-22
88801118892743K232322MAGNETOM Terra; MAGNETOM Terra.XLNH2024-03-22
88801394664289K232305AI-Rad Companion Brain MRQIH2023-10-23
88761569253614K232206SOMATOM Pro.PulseJAK2023-12-06
88761985741414K232155syngo.CT Dual EnergyJAK2023-11-30
88761637481819K232136syngo.CT ApplicationsJAK2024-01-04
88801438113068K231587MAGNETOM Cima.XLNH2023-12-18
88761226493349K231577MOBILETT ImpactIZL2023-07-25
88801302762395K231560MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fitLNH2023-10-23
88801454230277K231351Chondral QuantLLZ2023-07-13
88761525488488K231157syngo.CT Lung CAD (Version VD30)OEB2023-07-19
88761373025785K230955syngo Application SoftwareLLZ2023-12-20
88761943129420K230950ARTIS icono (VE30A)OWB2023-12-14
88761095295246K230949ARTIS pheno (VE30A)OWB2023-12-15
88761629078972K230561Syngo Carbon Space VA30ALLZ2023-03-21
88761703333667K230421SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition FlashJAK2023-06-16
88761475951337K230196syngo.via View&GO VA40ALLZ2023-02-13
88761094072417K223812Sensis Vibe (VD15)DQK2023-09-15
88762063753210K223363MAMMOVISTA B.smart (VB70)LLZ2023-01-12
88801634679431K222361AI-Rad Companion (Musculoskeletal)JAK2022-10-20
88801339679395K222360AI-Rad Companion (Cardiovascular)JAK2023-04-06
88801735283270K221733MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitLNH2022-09-13
88761296293721K221727syngo.CT Extended FunctionalityJAK2022-07-13
88761333060397K221516ARTIS icono (Ceiling Configuration)OWB2022-07-19
88761940636166K221501syngo.via View&GOLLZ2022-10-14
88801999975683K221305AI-Rad Companion Organs RTQKB2022-10-14
88761035715773K221281Multitom RaxOWB2022-11-17
88761060315058K221219syngo.CT CaScoringJAK2022-05-17
88801023118527K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ALNH2022-04-29
88761710749199K220814NAEOTOM Alpha, Scan&GO SoftwareJAK2022-07-12
88761345928754K220783syngo.via RT Image SuiteMUJ2022-09-07
88801033315865K220589MAGNETOM Skyra FitLNH2022-05-13
88761918873962K220450syngo.CT ApplicationsJAK2022-03-07
88761623651520K220433syngo Application Software (VE21)LLZ2022-08-16
88762039778139K220432ARTIS icono (VE21) SystemOWB2022-06-29
88801178054615K220425MAGNETOM Vida, MAGNETOM SolaLNH2022-03-11
88761536937719K220409ARTIS pheno (VE21) SystemOWB2022-06-29
88801066416272K220151MAGNETOM Avanto FitLNH2022-04-01
88762058729735K214019syngo.CT Extended FunctionalityJAK2022-01-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK1282026-03-20
LLZ942025-11-20
LNH822026-09-01
OWB392026-04-24
MOS122011-08-25
QIH112026-09-25
KPR102025-07-31
MUE82026-06-18
MUJ72024-04-26
OEB72023-07-19
IZI72018-05-03
OUO62026-01-15
QKB52026-04-10
JAA52011-06-03
DQK42023-09-15
IZL42023-07-25
LHN42017-04-05
LNS42012-06-12
OXO42005-06-01
QAS32025-04-10
NWE22014-12-03
IYE22008-06-04
LMC22007-10-25
IZH22001-02-02
IXA21995-04-03
IYO12022-03-16
MUA12021-02-25
MHX12020-06-08
DQA12017-12-15
PGY12015-07-30
OTE12015-04-21
HAW12002-06-14
IZZ11997-05-14
LNI11997-04-03
KPW11978-12-04

PMN#

GUDID#