BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UroNav 4

    Reg #: 3023385454 · FEI: 3023385454 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Philips DS North America LLC
    Registration Number
    3023385454
    FEI Number
    3023385454
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3630 SW 47th Avenue
    City
    Gainesville
    State
    FL
    ZIP
    32608
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250800

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Radiological Image Processing Software For Ablation Therapy Planning And Evaluation QTZ
    System, Image Processing, Radiological LLZ

    Proprietary Names

    UroNav 4

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility