BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Computer Vision AG

    Reg #: 3042928350 · FEI: 3042928350 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    5
    Classifications
    1

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    Registration Details

    Registration Name
    Computer Vision AG
    Registration Number
    3042928350
    FEI Number
    3042928350
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Zwicky-Platz 1
    City
    Wallisellen Zurich
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K242607

    Owner / Operator

    Firm Name
    Computer Vision AG
    Operator Number
    10094920
    Address
    Zwicky-Platz 1
    City
    Wallisellen
    State
    Zurich
    Postal Code
    8304
    Country
    CH

    US Agent

    Business Name
    Emeralgo Inc.
    Contact Name
    Rene Balzano
    Address
    610 E Zack St Ste 110-3058
    City
    Tampa
    State
    FL
    ZIP
    33602
    Country
    US
    Email
    [email protected]
    Phone
    813 5709797

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Emeralgo Ortho L-Spine MR-Q

    Establishment Types

    Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device