BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BriefCase-Quantification

    DI: 07290018052266 · Model: BC.QTF.4.x.y · AIDOC MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BriefCase-Quantification
    Primary DI
    07290018052266
    Version / Model
    BC.QTF.4.x.y
    Company Name
    AIDOC MEDICAL LTD
    Labeler DUNS
    532230094
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-04
    Public Version
    2
    Public Version Date
    2026-02-12
    Public Version Status
    Update
    Public Device Record Key
    157fa8e2-859a-4988-84bd-c6c39dce6a8c

    Device Description

    BriefCase-Quantification is an Automated Radiological Image Processing Software.

    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
    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
    QIH Automated Radiological Image Processing Software

    GMDN Terms

    Code Name
    57812 Radiology DICOM image processing application software

    Identifiers

    Type ID
    Primary 07290018052266

    Premarket Submissions

    Submission Number Supplement Number
    K230534 000
    K231631 000
    K232083 000
    K241112 000