BEUDAMED
    FDA Registration Active 🇨🇳 China

    SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.

    Reg #: 3004754211 · FEI: 3004754211 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    119
    Establishment Types
    4
    Classifications
    8

    Registration Details

    Registration Name
    SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
    Registration Number
    3004754211
    FEI Number
    3004754211
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    SIEMEN MRI CENTER, Gaoxin C.Ave.,2nd, Hi-Tech Industrial Park
    City
    SHENZHEN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232765

    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, Nuclear Magnetic Resonance Spectroscopic LNI
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Imaging LNH
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance OUO
    System, Tomography, Computed, Emission KPS
    Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use) MOH

    Proprietary Names

    MAGNETOM Cima.X Fit MAGNETOM Flow.Ace MAGNETOM Flow.Plus XA70A MAGNETOM Combi Suite Neurosurgery for MAGNETOM systems Aera and Skyra. SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/ VERIO MAGNETOM Sola w/XJ gradient system MAGNETOM SOLA MAGNETOM Skyra MAGNETOM Aera SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS MAGNETOM Amira MAGNETOM Flow.Elite MAGNETOM Vida Fit MAGNETOM Vida MAGNETOM Flow.Rise MAGNETOM Viato.Mobile MAGNETOM Lumina Syngo MR XB10A MAGNETOM Sola MAGNETOM Altea MAGNETOM Flow.Neo MAGNETOM Sola Fit AP02 Compressed Sensing MAGNETOM Aera with syngo MR MAGNETOM Skyra with syngo MR MAGNETOM Sola with syngo MR XA51A MAGNETOM Sola Fit with syngo MR XA51A MAGNETOM Altea with syngo MR XA51A MAGNETOM Lumina with syngo MR XA50A MAGNETOM Vida Fit with syngo MR XA50A Syngo MR XB10 MAGNETOM Skyra Fit MAGNETOM Avanto Fit MAGNETOM Sola w/syngo MR XA11A MAGNETOM Altea with SW syngo MR XA11B 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA Artis One Artis One Angiographic System ARTIS one Edition X Magnetom Spectra MAGNETOM Aera with syngo SW XA30A MAGNETOM Skyra with syngo SW XA30A MAGNETOM Prisma/ Prismafit with syngo SW XA30A syngo MR XA10A BIOGRAPH One MAGNETOM Cima.X MAGNETOM Spectra with syngo MR E11M MAGNETOM Spectra 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 Sempra syngo MR E11S MAGNETOM Sempra with syngo MR E11S MAGNETOM Skyra with syngo MR D11 MAGNETOM Aera with syngo MR D11 MAGNETOM Aera with syngo MR D13E MAGNETOM Aera 1.5T System 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 MAGNETOM C! System MAGNETOM Artis Combi Suite Magnetom Essenza MAGNETOM Free.Max MAGNETOM Amira with software syngo MR E11S MAGNETOM ESSENZA WITH SYNGO MR D14 MAGNETOM Aera (MR E11C-AP01) VD13A Quiet MRI and Fast Reliable Body MRI syngo MR E11Q syngo MR E11Q SW for the MAGNETOM ESSENZA MAGNETOM Altea with syngo MR XA61A MAGNETOM Sola with syngo MR XA61A MAGNETOM Vida with syngo MR XA31A MAGNETOM Sola with syngo MR XA31A MAGNETOM Altea with syngo MR XA31A MAGNETOM Lumina with syngo MR XA31A MAGNETOM Aera - Mobile Solution with Tim Dockable Table MAGNETOM Sempra (syngo MR XA12M) MAGNETOM Amira (syngo MR XA12M) MAGNETOM Mica 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 Magnetom C! Magnetom C! System 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 Free.Star XA80A 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 MAGNETOM Vida with syngo MR XA50A 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 SPECIALTY COILS FOR THE MAGNETOM ESSENZA MAGNETOM Vida with Nexaris Angio-MR MAGNETOM Sola with Nexaris Angio-MR MAGNETOM Verio MR E11D MAGNETOM Verio w/syngo MR E11D MAGNETOM Avanto MR E11D MAGNETOM Avanto MAGNETOM Avanto w/syngo MR E11D MAGNETOM Verio MAGNETOM Free.Max with syngo XA60A MAGNETOM Free.Star with syngo XA60A MAGNETOM Free.Star with syngo MR XA50A MAGNETOM Free.Max with syngo MR XA50A

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility