BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIRONA MEDICAL, INC.

    Reg #: 3018133052 · FEI: 3018133052 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SIRONA MEDICAL, INC.
    Registration Number
    3018133052
    FEI Number
    3018133052
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    171 2nd St
    City
    San Francisco
    State
    CA
    ZIP
    94105
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251030

    Owner / Operator

    Firm Name
    Sirona Medical, Inc.
    Operator Number
    10081021
    Address
    171 2nd St
    City
    San Francisco
    State
    CA
    Postal Code
    94105
    Country
    US
    Correspondent
    Patrice J Nedelec

    Products

    Device Name Product Code
    System, Digital Image Communications, Radiological LMD
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Sirona Advanced Imaging Suite Sirona PET Module

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198