BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    PowerLook Tomo Detection (ProFound AI)

    DI: 00858012005939 · Model: V2 · Icad, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PowerLook Tomo Detection (ProFound AI)
    Primary DI
    00858012005939
    Version / Model
    V2
    Company Name
    Icad, Inc.
    Labeler DUNS
    108870254
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-12-27
    Public Version
    2
    Public Version Date
    2019-07-12
    Public Version Status
    Update
    Public Device Record Key
    7b66ec62-b820-4371-b8cd-1844e52eddb8
    Distribution End Date
    2019-07-10

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Serial Number
    No
    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
    QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

    GMDN Terms

    Code Name
    40866 Basic diagnostic x-ray system application software

    Identifiers

    Type ID
    Primary 00858012005939

    Customer Contacts

    Phone
    (866) 280-2239
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K182373 000