BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Siemens Healthineers AG

    Reg #: 3004977335 · FEI: 3004977335 · Expires 2026
    View on FDA
    Products
    45
    Proprietary Names
    423
    Establishment Types
    5
    Classifications
    45

    Registration Details

    Registration Name
    Siemens Healthineers AG
    Registration Number
    3004977335
    FEI Number
    3004977335
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    SIEMENSSTRASSE 1 -OR-, Rittigfeld 1
    City
    FORCHHEIM Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K112020
    PMA Number
    P140011

    Owner / Operator

    Firm Name
    Siemens Healthineers AG
    Operator Number
    8010024
    Address
    Karlheinz-Kaske-Str. 5, --
    City
    Erlangen
    State
    DE-NOTA
    Postal Code
    91052
    Country
    DE

    US Agent

    Business Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Contact Name
    Robert Phillips
    Address
    40 Liberty Boulevard
    City
    MALVERN
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    302 2359839

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    Cassette, Radiographic Film IXA
    Radiological Computer-Assisted Triage And Notification Software QAS
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Image Processing, Radiological LLZ
    System, X-Ray, Angiographic IZI
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    Full Field Digital, System, X-Ray, Mammographic MUE
    Colon Computed Tomography System, Computer Aided Detection NWE
    Camera, Multi Format, Radiological LMC
    System, X-Ray, Stationary KPR
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, Planning, Radiation Therapy Treatment MUJ
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Lung Computed Tomography System, Computer-Aided Detection OEB
    System, Radiation Therapy, Charged-Particle, Medical LHN
    System, X-Ray, Mobile IZL
    Lithotriptor, Extracorporeal Shock-Wave, Urological LNS
    System, X-Ray, Mammographic IZH
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    Computer, Diagnostic, Programmable DQK
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Computer, Blood-Pressure DSK
    Monitor, St Segment With Alarm MLD
    Oximeter DQA
    Continuous Measurement Thermometer FLL
    Detector And Alarm, Arrhythmia DSI
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    Table, Radiographic, Tilting IXR
    Densitometer, Bone KGI
    Automated Radiological Image Processing Software QIH
    Ultrasonic Body Composition Analyzer OMV
    Bone Sonometer MUA
    Holder, Film, X-Ray EGZ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Table, Radiographic, Non-Tilting, Powered IZZ
    Digital Breast Tomosynthesis OTE
    Coil, Magnetic Resonance, Specialty MOS
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Probe, Thermodilution KRB
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Alarm, Blood-Pressure DSJ

    Proprietary Names

    syngo. CT Vascular Analysis AI Rad Companion (Musculoskeletal) Somatom Perspective 16 & 32 slice config KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7) iterative Metal Artifact Reconstruction Software iMAR software syngo.CT Brain Hemorrhage syngo Virtual Cockpit (VB10A) syngo.CT Single Source Dual Energy (twin beam) VB20 Twin Beam SOMATOM X.ceed SOMATOM X.cite ARTIS ZEE / ZEEGO WITH SW VC14 AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM syngo Aortic ValveGuide Software ARTIS icono (VE30A) X-Leonardo syngo.Interventional MAMMOMAT Revelation syngo Neuro PBV IR SOMATOM CT Systems with VC50 SW - SOMATOM Perspective, SOMATOM Scope/Scope Power and SOMATOM Emotion 16 syngo Carbon Enterprise Access (VA40A) SOMATOM Definition AS Open VA48 SOMATOM Definition AS Open SOMATOM Force SOMATOM Definition Confidence SOMATOM Definition AS/AS+ SOMATOM Definition Edge SOMATOM Definition Flash SOMATOM Drive ARTIS genio floor (VE50B) ARTIS icono.explore floor (VE50B) Mammomat Fusion syngo.CT Colonography - Software Package with Extended Functionality Drystar AXYS syngo.CT Coronary Analysis syngo.CT Vascular Analysis Multitom Rax with True2scale Body Scan Option Ysio SYNGO VOLUME PERFUSION-CT NEURO SOMATOM DEFINITION, MODEL AS/AS+ SOMATOM Perspective (with syngo® CT VC30-easyIQ version) SOMATOM Perspective syngo Application Software VD11 Additional Pixium 2430 EZ-C ArtPix Mobile EZ2GO Additional Pixium 3543 EZ-C syngo.via RT Image Suite (VB70) syngo.MR General syngo.MR Vascular syngo.MR Cardiology AX WORKSTATION DR-VIEWER SOFTWARE OPTION SYNGO.MR SPECTRO ENGINE SYNGO.MR SPECTRO SVS SYNGO.MR SPECTRO CSI SYNGO.MR SPECTRO EXTENSION Cios Spin (VA30G) LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY MODIFICATION TO SYNGO INSPACE 4D SOMATOM Force with SOMARIS/7 syngo CT VB30 SOMATOM Definition Edge with SOMARIS/7 syngo CT VB30 SOMATOM Edge Plus with SOMARIS/7 syngo CT VB30 SOMATOM Definition Flash with SOMARIS/7 syngo CT VB30 SOMATOM Definition AS/AS+ with SOMARIS/7 syngo CT VB30 SOMATOM Drive with SOMARIS/7 syngo CT VB30 SOMATOM Confidence with SOMARIS/7 syngo CT VB30 SOMATOM Definition AS Open with SOMARIS/7 syngo CT VB30 AZ-733 Respiratory Gatinn System ANZAI AZ-733 RESPIRATORY GATING SYSTEM syngo DynaPBV Body Software SOMATOM X.cite with SOMARIS/10 syngo CT VA 30 Scan&GO with SOMARIS/10 syngo CT VA 30 MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY TOP ACOM STATION syngo.MR Neurology syngo Perfusion-CT INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY Inspace 4D syngo Application Software syngo.CT Cardiac Function UROSKOP OMNIA UROSKOP Omnia Max MAMMOVISTA B.smart syngo Neuro DSA CT syngo.CT Dual Energy syngo.via RT Image Suite software version SOMARIS/8 VB50 Syngo Colonography syngo.CT LVO Detection (VB80) syngo expert I SOMATOM CARE CONTRAST CT syngo.CT Skull Unfolding syngo.Breast care AX Workstation syngo.CT Applications Dyna CT ARTIS pheno (VE50B) ARTIS icono Biplane (VE50B) ARTIS icono Floor (VE50B) ARTIS icono Ceiling (VE50B) syngo Dynamics Version VA30 syngo X-Workplace SW VD10 Syngo.CT Lung CAD syngo.CT Lung CAD (VD20) Multitom Rax ARTIS pheno Pulmo CT with Reference Database for the SOMATOM Plus and Plus 4 MOBILETTE XP AND MOBILETT XPHYBRID syngo.CT Neuro Perfusion Cios Alpha (VA30G) syngo Carbon Space (VA30A) MAMMOMAT INSPIRATION MODULARIS VARIOSTAR Somatom Definition AS Open (Somaris/7 VA46A) Somatom Force Arcadis Avantic YSIO X.pree (VA20) Luminos dRF Max Uroskop Omnia Max Luminos Agile Max Luminos Lotus Max MAMMOMAT INSPIRATION PRIME MAMMOMAT 300 AND MAMMOMAT 3000 syngo.CT Extended Functionality AI-Rad Companion (Pulmonary) MAMMOMAT Revelation (VC20) SOMATOM DEFINITION FLASH ARTIS pheno (VE30A) syngo.CT View&GO SYNGO, CT CARDIAC FUNCTION Arcadis Varic SIREMOBILE C06 syngo.CT Dual Energy (VB71) syngo.via (Version VB40A) ARTIS icono (VE23) MULTIX Impact E syngo application software version VD20 Multix Fusion Max SYNGO SINGLE SOURCE DUAL ENGERY FLUOROSPOT COMPACT SOMATOM Edge Plus SOMATOM go.Now SOMATOM go.Up SMB Family Opti Family Athlon Family RAY Family SIREPHOS Family OPTIPHOS Family Gigalix Family Megalix Cat Family S3P-Monoblock TR Family Megalix Family Megalix Cat Plus Family P40 MoW-100G Vectron Family CHRONON Family DURA Family Optilix Family STRATON Family Optitop Family Angiolux Family SOMATOM X.cite, with SOMARIS/10 syngo CT VA30 (Update) Scan&GO, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go.Up, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go.Top, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go. Open Pro, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go. Now, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go.All, with SOMARIS/10 syngo CT VA30 (Update) SOMATOM go.Sim, with SOMARIS/10 syngo CT VA30 (Update) Sensis Sensis Vibe syngo True D MULTIX Impact C syngo.CT Brain Hemorrhage (VB80) ARTIS pheno (VE2) syngo.CT Lung CAD Mindray Patient Monitoring System SOMATOM go.Top with SOMARIS/10 syngo CT VB20 SOMATOM go.Now with SOMARIS/10 syngo CT VB20 SOMATOM go.Up with SOMARIS/10 syngo CT VB20 SOMATOM go.Sim with SOMARIS/10 syngo CT VB20 SOMATOM go.All with SOMARIS/10 syngo CT VB20 SOMATOM go.Open Pro with SOMARIS/10 syngo CT VB20 SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20 syngo.CT Myocardial Perfusion Multix Fusion SOMATOM DEFINITION syngo.via VA20 (with Alpha Algorithm) syngo.CT CaScoring with software SOMARIS/8 VB40 syngo.CT Dual Energy (VB10) MULTIX Impact LEONARDO SYNGO CARDIOLOGY WORKSTATION SOMATOM RESPIRATORY GATING MAMMOREPORT SOFTCOPY WORKSTATION NAEOTOM Alpha, Scan&GO with SOMARIS/10 syngo CT VA50 Ysio Max Ysio Max Rad X-ray system (modular system of X-Ray) SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE syngo.via View&Go (VA40A) SOMATOM Definition Edge with SOMARIS/7 syngo CT VB20 SOMATOM Drive with SOMARIS/7 syngo CT VB20 SOMATOM Definition AS/AS+ with SOMARIS/7 syngo CT VB20 SOMATOM Confidence with SOMARIS/7 syngo CT VB20 SOMATOM Edge Plus with SOMARIS/7 syngo CT VB20 SOMATOM Definition AS Open with SOMARIS/7 syngo CT VB20 SOMATOM Definition Flash with SOMARIS/7 syngo CT VB20 SOMATOM Force with SOMARIS/7 syngo CT VB20 SOMATOM Emotion 6 syngo.MR Applications with new software version SMR VB40A syngo.MR Applications Cios Flow ARTIS Q MODULAR ANGIOGRAPHIC SYSTEM ARTIS Q.ZEN MODULAR ANGIOGRAPHIC SYSTEM Polydoros F / Polydoros R Family Polydoros A100 Family Polydoros RF Family Polydoros RFX Polydoros ACX ARCADIS ORBIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) Admire SOMATOM P47 SOMATOM Flash DS ARTIS pheno (VE21) syngo.CT Liver Analysis Siremobil Compact L Siremobil Compact ARTIS icono (VE21) SOMATOM Definition Flash with Stellar Detector Uroskop U04 endourological R/F system CALCIUM SCORING syngo Application Software (VD20) syngo Neuro PBV CT syngo.via RT Image Suite (VB80) IN SPACE 3D Artis DIGITAL IMAGING SYSTEM (BSR) Artis zee / zeego Artis Q and Artis Q.zen SOMATOM SENSATION 64 AND SENSATION CARDIAC AZ-733VI Respiratory Gating System NAEOTOM Alpha with SOMARIS/10 syngo CT VB10 Sliding Gantry Option for CT Devices syngo dual energy MODULTH SLK TILTING BUCKY TABLE POLYSTAR syngo mMR General SOMATOM On.site with software version SOMARIS/10 syngo CT VB10 MAMMOVISTA B.smart VB70 SYNGO, CT BONE READING syngo Application Software (VE40C) SOMATOM go.Now, with SOMARIS/10 syngo CT VA30 SOMATOM go.Open Pro, with SOMARIS/10 syngo CT VA30 SOMATOM go.Top, with SOMARIS/10 syngo CT VA30 SOMATOM go.Sim, with SOMARIS/10 syngo CT VA30 SOMATOM go.All, with SOMARIS/10 syngo CT VA30 SOMATOM go.Up, with SOMARIS/10 syngo CT VA30 Scan&Go, with SOMARIS/10 syngo CT VA30 syngo.via Webviewer Mobilett Impact ADMIRE Quantitative Dose Reduction ADMIRE ARTIS icono (VE2) System SOMATOM go.Open Pro with SOMARIS/10 syngo CT VB10 SOMATOM X.cite with SOMARIS/10 syngo CT VB10 SOMATOM X.ceed with SOMARIS/10 syngo CT VB10 SOMATOM go.Up with SOMARIS/10 syngo CT VB10 SOMATOM go.Top with SOMARIS/10 syngo CT VB10 SOMATOM go.All with SOMARIS/10 syngo CT VB10 SOMATOM go.Now with SOMARIS/10 syngo CT VB10 SOMATOM go.Sim with SOMARIS/10 syngo CT VB10 SOMATOM go.TOP SOMATOM go.All Scan&GO 3D CT Reconstruction Software LungCARE CT software package Multix Fusion Max w/SW VF10 syngo Application Software (VE30A) SOMATOM Definition Flash with SOMARIS/7 VA48 NAEOTOM Alpha.Pro with SW SOMARIS/10 syngo CT VB20 NAEOTOM Alpha.Prime with SW SOMARIS/10 syngo CT VB20 NAEOTOM Alpha/NAEOTOM Alpha.Peak with SW SOMARIS/10 syngo CT VB20 AXIOM SIRESKOP SD syngo.CT Dual Energy (VC10) Scan&Go AI-Rad Companion (Cardiovascular) SYNGO INSPACE 4D SOMATOM Confidence® RT Pro Multix Fusion VA30 and VA40 syngo. plaza VB10A YSIO X.pree 3D-ANGIO SAFIRE Cios Alpha Cios Alpha (SW VA30) SOMATOM P30 CT SYSTEMS ( Emotion MS- multislice) Sensis Lite Cios Spin (VA31A) SYNGO CT ONCOLOGY SOFTWARE PACKAGE syngo.CT Single Source Dual Energy (VB10) syngo.CT Single Source Dual Energy sungo.CT Pulmo 3D syngo.MR Applications (VB80) MAMMOMAT B.brilliant SOMATOM Project P68 OPDIMA SOMATOM go.All with SOMARIS/10 syngo CT VA40 SOMATOM go.Up with SOMARIS/10 syngo CT VA40 SOMATOM go.Sim with SOMARIS/10 syngo CT VA40 SOMATOM X.cite with SOMARIS/10 syngo CT VA40 SOMATOM X.ceed with SOMARIS/10 syngo CT VA40 SOMATOM go.Top with SOMARIS/10 syngo CT VA40 SOMATOM go.Now with SOMARIS/10 syngo CT VA40 SOMATOM go.Open Pro with SOMARIS/10 syngo CT VA40 Scan&GO Software with SOMARIS/10 syngo CT VA40 syngo.RT Image Suite ARTIS ZEE/ZEEGO SW VC21 (with CARE claims) Low Dose Lung Cancer Screening for Siemens Computed Tomography (CT) Systems. Low Dose Lung Cancer Screening SOMATOM Definition Edge, SOMATOM Definition AS/AS+ FAST DE Results for Twin Beam Data post processing application for Definition AS/AS+ FAST DE Results for Twin Beam Data post processing application FAST DE Results for Twin Beam Data post processing application for Definition Edge syngo.CT CaScoring Mammomat Fusion with Stereotactic Biopsy syngo.MR General VB20 AXIOM LUMINOS DRF Mobilett Mira Max Mobilett Mira NEWCOR CIARTIC Move (VB10) syngo.via View&Go (VA30A) OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS SOMATOM Scope Power (with syngo® CT VC30-easyIQ version) SOMATOM Scope (with syngo® CT VC30- easyIQ version) Lithotriptor LITHOSKOP MR VB10 software upgrade syngo.MR Oncology syngo Application Software (VE51) Cios Spin (VA30) Cios Spin NAEOTOM Alpha.Prime with SOMARIS/10 syngo CT VB20 NAEOTOM Alpha.Peak with SOMARIS/10 syngo CT VB20 NAEOTOM Alpha with SOMARIS/10 syngo CT VB20 NAEOTOM Alpha.Pro with SOMARIS/10 syngo CT VB20 SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY syngo.CT CaScoring SOMARIS/8 VB50 Cios Connect EchoS Family syngo.via (version VB10A) syngo.mMR General syngo.MR BreVis ARTIS icono (VE40A) (biplane) ARTIS pheno (VE40A) ARTIS icono (VE40A) (ceiling) ARTIS icono (VE40A) (floor) Insight BD syngo' Dual Energ with extended functionality syngo.CT Dual Energy (VB80) Syngo LUNG CAD Kenex Mobile Cassett Holder ARTIS ZEE AND ZEEGO syngo.via View&GO (VA20A) syngo® Volume Perfusion-CT Body syngo.CT Dental SYNGO. PLAZA VA20A syngo Dynamics SOMATOM Definition Edge VA48 software PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) syngo.CT Lung CAD (VD30) SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 syngo. CT Dynamic Anglo EchoSK and EchoSGyn modules for EchoS Family devices MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE syngo.MR Brain MULTIX Impact E VB20 syngo Carbon Space (VA20A) Extended Field of View (FoV) Software Package NAEOTOM Alpha, Scan&GO with SOMARIS/10 syngo CT VA40 Luminos Agile Luminos Agile (Max) ARTIS icono (VE2) SOMATOM Emotion 16 LUMINOS Q.namix T LUMINOS Q.namix R Artis zee with CSX 10 Detector VC21 Artis zeego with CSX 10 Detector VC21 Somatom Definition with software version SOMARIS/7 VA44 SOMATOM P45 syngo.CT Cardiac Planning Cios Fusion Somatom Drive SYNGO CIRCULATION Mammomat Inspiration with Tomosynthesis option Mammomat Revelation with Tomosynthesis option MAMMOMAT B.brilliant with Tomosynthesis Option SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS syngo CT Dual Energy Siemens SOMATOM Definition AS/AS+ with software version syngo ® VA48 (SOMARIS/7 VA48) syngo Carbon Clinicals (VA41) syngo Application Software (VE21) syngo Dual Energy with extended functionality Cios Alpha VA20 Cios Alpha VA10 SYNGO BODY PERFUSION-CT AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM Sensis Vibe Combo (VD15B) Sensis Vibe Hemo (VD15B) SYNGO DUAL ENERGY SOFTWARE PACkage VA11 syngo Application Software (VD11) VB20 Extended Functionality MOBILETT Elara Max (SW VF10) Artis One Artis One Angiographic System ARTIS one Edition X SOMATOM DEFINITION EDGE syngo®.plaza Syngo Carbon Clinicals AI-Rad Companion (Engine)

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)