BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    QUANTIB BV

    Reg #: 3013497030 · FEI: 3013497030 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    QUANTIB BV
    Registration Number
    3013497030
    FEI Number
    3013497030
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Westblaak 130
    City
    Rotterdam Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K213737

    Owner / Operator

    Firm Name
    Quantib BV
    Operator Number
    10052143
    Address
    Westblaak 130
    City
    Rotterdam
    State
    Zuid-Holland
    Postal Code
    3012KM
    Country
    NL
    Correspondent
    B. Nathan Hunt

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Quantib ND Saige Brain Quantib Brain 1.2 Quantib AI Node Saige AI Node Quantib Prostate Saige Prostate DeepHealth Prostate Quantib Brain 1 Brain Health Quantib Brain 1.3

    Establishment Types

    Manufacture Medical Device