BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Siemens Healthineers AG

    Reg #: 3002808157 · FEI: 3002808157 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    255
    Establishment Types
    5
    Classifications
    20

    Registration Details

    Registration Name
    Siemens Healthineers AG
    Registration Number
    3002808157
    FEI Number
    3002808157
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Allee am Rothelheimpark 2
    City
    ERLANGEN Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K242551

    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 6319702

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ
    System, Nuclear Magnetic Resonance Imaging LNH
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    System, X-Ray, Tomography, Computed JAK
    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance OUO
    Radiological Image Processing Software For Radiation Therapy QKB
    Display, Diagnostic Radiology PGY
    Stand, Infusion FOX
    System, Tomography, Computed, Emission KPS
    Grid, Radiographic IXJ
    Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use) MOH
    System, Planning, Radiation Therapy Treatment MUJ
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    Holder, Head, Neurosurgical (Skull Clamp) HBL
    Accelerator, Linear, Medical IYE
    Neurological Stereotaxic Instrument HAW
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    Medical Device Data System OUG

    Proprietary Names

    syngo Dynamics (VA41D) syngo.MR General VB20 syngo.MR General SYNGO MR B17 MAGNETOM Terra (syngo MR E12U) MAGNETOM Terra AI-Rad Companion (Pulmonary) VA40 syngo.via VA20 (without Alpha Algorithm) Noras - OR HEAD COIL 1.5 T AI-Rad Companion (Pulmonary) VA20 Biograph mMR VB20P Software syngo MR B20P for Biograph mMR CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow MAGNETOM Aera with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow MAGNETOM TRIO A TIM SYSTEM AI-Rad Companion Organs RT (VA40) MAGNETOM Free.Max MAGNETOM Skyra Fit with syngo MR XA50A ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS 5MP Monochrome LCD Monitor, RadiForce GX540 syngo MR E11C software for MAGNETOM Avantofit MR Systems syngo MR E11C software for MAGNETOM Skyrafit MR Systems MAGNETOM Free.Star XA80A Chondral Quant 6 CHANNEL BODY COIL MAGNETOM Trio MAGNETOM Systems with SW syngo MR 2006A (SW VB13) MAGNETOM Symphony MAGNETOM Espree MAGNETOM Avanto Chapot Table System syngo BreVis Biopsy MRWP # Tim syngo BreVis MRWP # Tim MAGNETOM VIDA MAGNETOM Lumina MAGNETOM Lumina (syngo MR XA11B) syngo.MR Applications with new software version SMR VB40A syngo.MR Applications MAGNETOM Sempra MAGNETOM Amira MAGNETOM Skyra with syngo MR D11 MAGNETOM Aera with syngo MR D11 AI-Rad Companion Prostate MR (VA60) AI-Rad Companion Brain MR (VA60) BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS MAGNETOM Aera with syngo SW XA30A MAGNETOM Skyra with syngo SW XA30A MAGNETOM Prisma/ Prismafit with syngo SW XA30A MAGNETOM Amira with software syngo MR E11S syngo.MR Oncology MAGNETOM Altea MAGNETOM Sola MAGNETOM Sola w/syngo MR XA11A MAGNETOM Altea with SW syngo MR XA11B CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM AI-Rad Companion Prostate MR Tim TX TrueShape and VD13C for MAGNETOM Skyra CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM MAGNETOM Skyra Fit MAGNETOM Sola Fit MAGNETOM Viato.Mobile XA70A MAGNETOM Avanto Fit MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A NORAS Surgery Head Coil, Set, 3T OR 8-channel coil #Es NORAS Head Coil-Bottom Half Only Noras OR Head Holder + Coil Set 3T OR Head Coil 3T MAGNETOM Altea with syngo MR XA61A MAGNETOM Sola with syngo MR XA61A Biograph mMR MAGNETOM Sola w/XJ gradient system MAGNETOM SOLA MAGNETOM Terra with syngo MR XA60A MAGNETOM Terra.X (7T) with syngo MR XA60A MAGNETOM Sempra (syngo MR XA12M) MAGNETOM Amira (syngo MR XA12M) MAGNETOM Mica MR VB10 software upgrade syngo.MR Neurology MAGNETOM Vida with syngo MR XA50A MAGNEITOM Systems I -class and] T-class releases syngo MR BI 5 MAGNETOM Vida MAGNETOM Vida Fit MAGNETOM AVANTO MR SYSTEM MAGNETIC CONCERTO MAGNETOM Sola with syngo MR XA51A MAGNETOM Sola Fit with syngo MR XA51A MAGNETOM Altea with syngo MR XA51A syngo.mMR General syngo.MR BreVis MAGNETOM Avantofit with syngo MR E11C-AP04 SW MAGNETOM Prismafit with syngo MR E11C-AP04 SW MAGNETOM Aera with syngo MR E11C-AP04 SW MAGNETOM Skyra with syngo MR E11C-AP04 SW MAGNETOM Prisma with syngo MR E11C-AP04 SW MAGNETOM Skyrafit with syngo MR E11C-AP04 SW MAGNETOM Artis Combi Suite MAGNETOM SYMPHONY A TIM SYSTEM MAGNETOM Flow.Elite MAGNETOM Flow.Rise Syngo MR XB10A MAGNETOM Flow.Neo AI-Rad Companion Organs RT (VA20) AI-Rad Companion Organs RT (VA70A) Innovision Audio Biograph mMR with mMR Angio Transfer Option AI-Rad Companion (Cardiovascular) VA20 MAGNETOM ESSENZA WITH SYNGO MR D14 syngo mMR General CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS Stationary X-Ray Grid Magnetom Prisma Magnetom Prisma fit AI-Rad Companion Brain MR VA20 CORDLESS COIL - Magnetom MAGNETOM ESPREE SYSTEM OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS MAGNETOM Viato.Mobile with syngo MR XA51A with XQ Gradient MAGNETOM Vida with Nexaris Angio-MR MAGNETOM Sola with Nexaris Angio-MR syngo MR XA10A BIOGRAPH One MAGNETOM Verio MR E11D MAGNETOM Verio w/syngo MR E11D MAGNETOM Avanto MR E11D MAGNETOM Avanto w/syngo MR E11D MAGNETOM Verio NUMARIS 4VA15A software MAGNETOM Vida with Compressed Sensing GRASP-VIBE AI-Rad Companion Engine 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA syngo.MR Brain MAGNETOM Cima.X syngo MR E11Q syngo MR E11Q SW for the MAGNETOM ESSENZA SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM MAGNETOM Skyra MAGNETOM Aera MAGNETOM Aera (MR E11C-AP01) MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016 FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR Syngo MR E11 Syngo MR E11 for MAGNETOM Aera (24) (1.5T), MAGNETOM Avantofit (1.5T), MAGNETOM Skyrafit (3T) and MAGNETOM Prisma/Prismafit (3T) VA10A LungMaps MAGNETOM Aera - Mobile Solution with Tim Dockable Table AI-Rad Companion Brain MR VA40 MAGNETOM Lumina with syngo MR XA50A MAGNETOM Vida Fit with syngo MR XA50A AI-Rad Companion Organs RT (VA60) syngo.MR Vascular syngo.MR Cardiology AI-Rad Companion (Musculoskeletal) VA20 Software syngo MR B19 for MAGNETOM Symphony A Tim System Software syngo MR B19 for MAGNETOM Espree Software syngo MR B19 for MAGNETOM Trio A Tim System Software syngo MR B19 for MAGNETOM Verio Software syngo MR B19 for MAGNETOM Avanto MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION Biograph mMR with syngo MR E11P System software MAGNETOM Avanto Fit with syngo MR XA50A SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/ VERIO MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) MAGNETOM Aera with syngo MR D13E MAGNETOM Aera 1.5T System MAGNETOM Avantofit with SW syngo VE11E 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA 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 Flex Loop Coil Set 3 T NORAS OR HEAD HOLDER - for Symphony/Sonata Table/Miyabi transport/Espree or TIM Trio AI-Rad Companion Organs RT (VA50) VD13A Quiet MRI and Fast Reliable Body MRI MRI Patient Positioning Device MAGNETOM Skyra fit with syngo XA61A MAGNETOM Avanto fit with syngo XA61A Endomap MAGNETOM Cima.X Fit RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials Magnetom Spectra INTERACTIVE REAL TIME SCANNING PACKAGE MAGNETOM Free.Max with syngo XA60A MAGNETOM Free.Star with syngo XA60A MAGNETOM Prisma with syngo MR XA60A MAGNETOM Aera with syngo MR XA60A MAGNETOM Skyra with syngo MR XA60A MAGNETOM Lumina with syngo MR XA60A MAGNETOM Prismafit with syngo MR XA60A MAGNETOM Vida with syngo MR XA60A MAGNETOM ALLEGRA SYSTEM MAGNETOM Spectra with syngo MR E11M MAGNETOM Spectra Biograph mMR with syngo MR E11P-AP01 system software MAGNETOM Sola with software syngo MR XA20A MAGNETOM Altea with software syngo MR XA20A MAGNETOM Sola Fit with software syngo MR XA20A MAGNETOM VERIO AI-Rad Companion Brain MR VA50 syngo MR 2002B syngo Computer HW Upgrade E11 AWP IDEA DVD E11A Software syngo MR E11A for the MAGNETOM systems Aera/Skyra syngo Comp. HW Upgrade E11 AWP+MRWP Head/Neck 64, Breast 18 and Body 18 long MAGNETOM Aera with software syngo MR D13A with add'l coils MAGNETOM Skyra with software syngo MR D13A with add'l coils Polydoros F / Polydoros R Family Polydoros A100 Family Polydoros RF Family Polydoros RFX Polydoros ACX Syngo MR XB10 MAGNETOM Flow.Plus MAGNETOM Flow.Ace SYNGO.MR SPECTRO ENGINE SYNGO.MR SPECTRO SVS SYNGO.MR SPECTRO CSI SYNGO.MR SPECTRO EXTENSION MAGNETOM Combi Suite Neurosurgery for MAGNETOM systems Aera and Skyra. MAGNETOM Free.Star with syngo MR XA50A MAGNETOM Free.Max with syngo MR XA50A MAGNETOM Vida (syngo MR XA11B) Flex and Loop Coil Set 1.5 T Innovision Display AP02 Compressed Sensing MAGNETOM Aera with syngo MR MAGNETOM Skyra with syngo MR MAGNETOM Vida with syngo MR XA31A MAGNETOM Sola with syngo MR XA31A MAGNETOM Altea with syngo MR XA31A MAGNETOM Lumina with syngo MR XA31A syngo MR E11C software for MAGNETOM Aera MR Systems syngo MR E11C syngo MR E11C software for MAGNETOM Prisma/Prismafit MR Systems syngo MR E11C software for MAGNETOM Skyra MR Systems

    Establishment Types

    Manufacture Medical 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) Export Device to the United States But Perform No Other Operation on Device