BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ClearRead CT Docker

    DI: M722CD20105V20040 · Model: 1.1.0 · Riverain Technologies, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ClearRead CT Docker
    Primary DI
    M722CD20105V20040
    Version / Model
    1.1.0
    Company Name
    Riverain Technologies, Inc.
    Labeler DUNS
    172223922
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-19
    Public Version
    6
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    0ae1e947-4c0e-4034-b855-9ec8e8b90321
    Distribution End Date
    2020-12-30

    Device Description

    ClearRead CT on Docker Platform Primary DI Number should be M722CD20105V200420. Re-entered 12/30/2020

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OEB Lung Computed Tomography System, Computer-Aided Detection
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary M722CD20105V20040