BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Caption AI (Caption Guidance + Caption Interpretation)

    DI: 00860003586341 · Model: Alastor · CAPTION HEALTH, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Caption AI (Caption Guidance + Caption Interpretation)
    Primary DI
    00860003586341
    Version / Model
    Alastor
    Company Name
    CAPTION HEALTH, INC.
    Labeler DUNS
    079192179
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-01
    Public Version
    4
    Public Version Date
    2025-07-29
    Public Version Status
    Update
    Public Device Record Key
    fc2b2f3c-085f-4c2c-9051-9ab2870a69a0
    Distribution End Date
    2025-07-25

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence
    QIH Automated Radiological Image Processing Software

    GMDN Terms

    Code Name
    40873 Ultrasound imaging system application software

    Identifiers

    Type ID
    Primary 00860003586341