BEUDAMED
    FDA Registration Active 🇫🇷 France

    BLOCK IMAGING SAS

    Reg #: 3023003446 · FEI: 3023003446 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    134
    Establishment Types
    1
    Classifications
    18

    Registration Details

    Registration Name
    BLOCK IMAGING SAS
    Registration Number
    3023003446
    FEI Number
    3023003446
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5 rue des Vosges
    City
    Weyersheim Bas-Rhin
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K041949
    PMA Number
    P010025

    Owner / Operator

    Firm Name
    Block Imaging SAS
    Operator Number
    10086857
    Address
    1845 Cedar Street
    City
    Holt
    State
    MI
    Postal Code
    48842
    Country
    US
    Correspondent
    Grace Lyon

    US Agent

    Business Name
    BLOCK IMAGING
    Contact Name
    Grace Lyon
    Address
    1845 Cedar Street
    City
    Holt
    State
    MI
    ZIP
    48842
    Country
    US
    Email
    [email protected]
    Phone
    517 6688800

    Products

    Device Name Product Code
    Full Field Digital, System, X-Ray, Mammographic MUE
    System, X-Ray, Angiographic IZI
    Coil, Magnetic Resonance, Specialty MOS
    System, X-Ray, Tomography, Computed JAK
    System, Nuclear Magnetic Resonance Imaging LNH
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    System, Tomography, Computed, Emission KPS
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    System, X-Ray, Mobile IZL
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Densitometer, Bone KGI
    System, Image Processing, Radiological LLZ
    System, X-Ray, Stationary KPR
    Digital Breast Tomosynthesis OTE
    System, X-Ray, Tomographic IZF

    Proprietary Names

    Hologic Selenia 2D Mammography Philips XPER FD10 Cath and Angio GE Head Neck and Spine Array Coil GE BrightSpeed Elite GE BrightSpeed Elite Select GE BrightSpeed Excel Select GE Brightspeed Elite 16 Slice CT GE BrightSpeed Edge Select GE Optima CT540 GE 750 3T MRI GE Performix tube Hologic 113T tube GE Discovery 690 PET/CT GE Discovery 600 PET/CT GE Discovery PET/CT GE Innova IGS 530 Cath Angio GE Innova 3131 Cath Siemens Biograph mCT PET/CT Siemens Somatom Perspective CT TxRx 15Ch Knee Coil Siemens SOMATOM go.All Siemens SOMATOM go.Top Siemens SOMATOM go.Up Siemens SOMATOM go.Now GE Optima XR240 Portable X-ray 3T Signa HDXT 1.5T Signa HDXT Signa Vibrant GE Discovery NM 530c (Ventri 1.1) GE Optima 660 CT GE Revolution EVO CT GE Innova 3100-IQ GE Innova 4100-IQ GE Innova 2100-IQ Siemens Somatom Definition AS CT Philips Achieva 3T MRI Philips Achieva 1.5T MRI OEC 9800 C-Arm GE Lunar Prodigy Advance GE Lunar Prodigy Primo GE Lunar Prodigy Siemens Somatom Scope CT Siemens Somatom Emotion CT Siemens MRI head coil GE LightSpeed VCT GE Senographe Pristina 3D Mammography Symbia Intevo Symbia T Symbia T16 Symbia T6 Symbia E Symbia T2 Symbia Intevo 6 Symbia Intevo Excel Symbia S Symbia Intevo 2 Symbia Intevo 16 GE 750W 3T MRI OEC 9900 Elite C-Arm GE Explorer 1.5T MRI Magnetom Avanto FIT Magnetom Skyra FIT Magnetom Prisma Fit GE Optima NM/CT 640 Philips Vereos PET/CT GE Discovery MI PET/CT Revolution HD CT GE Discovery 750HD CT Revolution Discovery CT Discovery CT GE LightSpeed VCT 64 Slice CT GE Discovery XR656 Rad Room Philips Allura Xper FD10 Philips Allura FD20/20 GE Essential Siemens Biograph Horizon - 4R Siemens Biograph Horizon Siemens Biograph Horizon - 3R GE Senographe Essential Mammography Philips FD 20/10 Hologic Dimensions 3D Mammo Medtronic O-Arm O2 Imaging System Siemens Skyra 3T MRI GE IGS 530 Cath GE Innova 3100 Cath GE Revolution CT GE Optima 450W 1.5T MRI GE DPX Bravo Bone Densitometer Philips Allura FD20 GE HDXT 1.5T MRI Siemens Artis Zee Cath Philips Ingenia 1.5T and 3T Siemens Biograph MCT 128 PET/CT Siemens Symbia T6 SPECT/CT Toshiba Aquilion 16 Slice CT GE Optima NM/CT 630 Hologic Discover DEXA Siemens Espree 1.5T MRI Siemens Somatom Sensation CT GE 0.2T Profile HD MRI OEC 9900 C-Arm SOMATOM Definition Flash SOMATOM Definition AS Open SOMATOM Force SOMATOM Definition Edge SOMATOM Definition AS/AS+ SOMATOM Definition Confidence SOMATOM Drive Siemens Aera 1.5T MRI Philips Azurion 3 M15 Cath Angio Siemens Symbia E Nuclear Camera GE Discovery 710 PET/CT Siemens Emotion 16 CT GE Optima 520 CT TxRx Knee 15 Flare MR Coil 1.5T GE Revolution HD CT GE Discovery IQ Siemens SOMATOM go.All CT GE Innova 2100 Cath Siemens Verio 3T MRI Siemens Symbia Intevo SPECT/CT Siemens Symbia E Siemens Symbia Evo Excel Siemens Symbia S Siemens Symbia Evo OEC Elite C-Arm Philips Brilliance CT Medtronic O-arm O2 Imaging System GE Discovery XR650 GE Revolution XR/d GE Optima XR640 GE Discovery XR656 GE Definium 8000 GE Discovery STE 16 PET/CT

    Establishment Types

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