BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ambra PACS

    Reg #: 3008776294 · FEI: 3008776294 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DICOM Grid (dba Ambra Health)
    Registration Number
    3008776294
    FEI Number
    3008776294
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    305 Church at North Hills St, 6th Floor
    City
    Raleigh
    State
    NC
    ZIP
    27609
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231360

    Owner / Operator

    Firm Name
    DICOM Grid dba Ambra Health dba Intelerad Holdings USA Ltd
    Operator Number
    10034899
    Address
    305 Church at N Hills St, 6th Floor
    City
    Raleigh
    State
    NC
    Postal Code
    27609
    Country
    US
    Correspondent
    Karen Kazak

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Ambra PACS InteleShare

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device