BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    PIE MEDICAL IMAGING B.V.

    Reg #: 9710122 · FEI: 3003595527 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    PIE MEDICAL IMAGING B.V.
    Registration Number
    9710122
    FEI Number
    3003595527
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Demertdwarsstraat 8A01
    City
    MAASTRICHT Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K052988

    Owner / Operator

    Firm Name
    Pie Medical Imaging B.V.
    Operator Number
    9045579
    Address
    Demertdwarsstraat 8A01
    City
    Maastricht
    State
    NL-NOTA
    Postal Code
    6227 AK
    Country
    NL
    Correspondent
    Annemiek Bouts

    US Agent

    Business Name
    EMERGO GLOBAL REPRESENTATION LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Caves Rd Ste 1 Ste 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device QHA
    System, X-Ray, Angiographic IZI
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    CAAS, CAASII, CAAS2000 CAAS Workstation Caas Qardia CAAS MR Solutions 3mensio Structural Heart 3mensio Workstation 3mensio Vascular CAAS QVA 3D CAAS QCA 3D

    Establishment Types

    Manufacture Medical Device