BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIEMENS MEDICAL SOLUTIONS USA, INC.

    Reg #: 1423253 · FEI: 1000514697 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    216
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Registration Number
    1423253
    FEI Number
    1000514697
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2501 NORTH BARRINGTON RD.
    City
    Hoffman Estates
    State
    IL
    ZIP
    60192
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193178

    Owner / Operator

    Firm Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Operator Number
    9002915
    Address
    40 Liberty Boulevard
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    System, Tomography, Computed, Emission KPS
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Biograph Horizon - VJ30 Biograph Horizon - 3R Biograph Horizon - 4R Biograph Horizon Scenium VE10 Scenium Symbia Intevo Bold Symbia 6.5 - VB20 Scenium VD20 Biograph Vision 600 Edge Biograph Vision 600 (8 Ring/64 CT) Biograph Vision 600 Edge (8 Ring/Edge) Biograph VIsion 600 Biograph mCT S(64)-3R Biograph mCT Flow 40-3R Biograph mCT Flow Edge-3R Biograph mCT Flow 20 Biograph mCT X Biograph mCT Flow 64-3R Biograph mCT X-4R Biograph mCT S(64)-4R Biograph mCT Flow 40-4R Biograph mCT Flow Edge Biograph mCT S 20 Excel Biograph mCT Flow 20-4R Biograph mCT 20 Excel Biograph mCT Flow 20-3R Biograph mCT Flow Biograph mCT S(20)-3R Biograph mCT S(20)-4R Biograph mCT S(40)-4R Biograph mCT Flow 64-4R Biograph mCT - VG70 Biograph mCT Flow 40 Biograph mCT S(40)-3R Biograph mCT X-3R Biograph mCT Flow Edge-4R Biograph mCT S Biograph mCT Flow 64 Biograph mCT Excel Biograph Horizon - VJ20 Scenium VE20 syngo.MI Reading (VA30A) syngo.CT LungCAD (VA30A) syngo.NM Reading (VA30A) syngo.MI Workplace syngo.MI Cardiology (VA30A) syngo.MI Taskflows syngo.SPECT Reading (VA30A) syngo.MI Neurology (VA30A) syngo.MM Oncology (VA30A) syngo.via MI Wokflows (VA30A) syngo.PET&CT Oncology (VA30A) syngo Circulation Dynamic PET syngo.PET Myocardial Blood Flow syngo.MBF - CFR 2 syngo.MBF syngo.MI Cardiology (VB10, VB10A) syngo.via MI Workflows VB10A syngo.via MI Taskflows syngo.MI Reading (VB10, VB10A) (aka syngo.SPECT Reading and / or syngo.NM Reading) syngo.MI Neurology (VB10, VB10A) syngo.PET&CT Oncology (VB10, VB10A) (aka syngo.MM Oncology (VB10, VB10A)) Symbia E Symbia T16 Symbia S Symbia E Single Symbia T6 Symbia T Symbia Evo Symbia Intevo 16 Symbia Intevo 6 Symbia 6.7 Symbia E Dual Symbia T2 Symbia Intevo 2 Symbia Evo Excel Symbia Intevo Excel syngo.NM Reading VB30A syngo.MI Reading VB30A syngo.MI Cardiology VB30A syngo.CT LungCAD VB30A syngo.PET&CT Oncology VB30A syngo.MI Neurology VB30A syngo.via MI Neurology VB30A syngo.MM Oncology VB30A syngo.via MI Workflows VB30A syngo.via MI Cardiology VB30A syngo.SPECT Reading VB30A syngo.SPECT Processing VB30A Biograph 16 TP-3R Biograph 40 TruePoint w/TrueV Biograph 16 TruePoint w/TrueV Biograph TruePoint Biograph 6 TruePoint w/TrueV Biograph 64 TP-3R Biograph 16 TruePoint Biograph 64 TP-4R Biograph 6 TP-3R Biograph 16 TP-4R Biograph 64 TruePoint Biograph 40 TP-4R Biograph 64 TruePoint w/TrueV Biograph 40 TP-3R Biograph 40 TruePoint Biograph 6 TP-4R Biograph 6 TruePoint Biograph Mission P Biograph Mission X Biograph Trinion.X EP9 CT128 Biograph Trinion.X EP5 CT64 Biograph Trinion.X EP5 CT128 Biograph Trinion.X EP9 CT64 Biograph Trinion EP CT128 Biograph Mission T Biograph Trinion EP2 CT128 Biograph Trinion EP CT64 Biograph Trinion EP2 CT64 Biograph Mission S Biograph Horizon - VJ10 syngo.MI Cardiology syngo.MI General syngo.MI Neurology syngo.NM Reading syngo.via MI Workflows syngo.MM Oncology syngo PET&CT Oncology syngo.via MI Workflows VB60A syngo.via MI Neurology syngo.SPECT Processing syngo.MI Reading Biograph mCT S (20)-4R Biograph mCT S (20)-3R Biograph mCT Biograph mCT S(20)-3R (aka Biograph mCT Excel) Biograph mCT - VG60 Symbia Pro.specta VA20 Symbia Pro.specta X3 Symbia Pro.specta X7 Symbia Pro.specta VA20A Symbia Pro.specta Q3 Biograph Vision 450 Biograph mCT - VG80 Biograph Vision 600 BIograph mCT S Biograph Vision - VG80 Biograph Vision 450 Edge Symbia VA10A Symbia.net Symbia VB23 Symbia Intevo c.cam Biograph mCT S (20) - 4R Biograph mCT Flow Edge - 4R Biograph Vision SOTA Biograph mCT S (20) - 3R Biograph mCT Flow Edge - 3R Biograph mCT X - 4R Biograph mCT S (64) - 4R Biograph mCT Flow 64 - 4R Biograph mCT Flow 20 - 4R Biograph mCT S (40) - 4R Biograph mCT Flow 20 - 3R Biograph mCT X - 3R Biograph mCT S (64) - 3R Biograph Vision Quantum Biograph Vision Peak Biograph mCT Flow 64 - 3R Biograph mCT Flow 40 - 4R Biograph mCT S (40) - 3R Biograph mCT Flow 40 - 3R Biograph Vision.X Edge Biograph Vision.X Biograph VK10 Biograph Vision Quadra Biograph Vision Quadra VR10 Biograph Vision Scenium Database Comparison syngo.MI Neurology VC10 syngo.MI General VC10 syngo MBF syngo.MM Oncology VC10 syngo.NM Organ Processing syngo.NM Organ Processing VC10 Scenium Cortical Analysis Scenium Subtraction Scenium Striatal Analysis syngo.MI Cardiology VC10 syngo PET Myocardial Blood Flow syngo.via MI Workflows VB80A Biograph Vision Quadra VR20 Symbia Pro.specta FAST Symbia Pro.specta SHARP Symbia Pro.specta SPEED Symbia Pro.specta VA40 Family Symbia Pro.specta LIGHT Symbia Pro.specta FLOW Symbia VA30A MI View&Go VA20 MI View&Go Symbia 6 - VB10 e.cam Scenium VE70A MI View&Go VA40 syngo.via MI Workflows VB20A syngo.MI Reading VB20A syngo.MM Oncology VB20A syngo.via MI Cardiology VB20A syngo.via MI Neurology VB20A syngo.PET&CT Oncology VB20A syngo.SPECT Reading VB20A MI View&Go VA30A syngo.SPECT Reading syngo.PET & CT Oncology Scenium VE30 syngo.via MI Workflows VB40A

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device