BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rapid

    DI: B7671R521 · Model: 5.2.2 · Ischemaview, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rapid
    Primary DI
    B7671R521
    Version / Model
    5.2.2
    Catalog Number
    Rapid
    Company Name
    Ischemaview, Inc.
    Labeler DUNS
    079477740
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-25
    Public Version
    3
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    e1c4d15c-b208-43f2-9183-a9b490050c1c

    Device Characteristics

    Single Use
    Yes
    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
    POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
    LLZ System, Image Processing, Radiological
    QAS Radiological Computer-Assisted Triage And Notification Software

    GMDN Terms

    Code Name
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary B7671R521

    Premarket Submissions

    Submission Number Supplement Number
    K182130 000
    K193087 000
    K200760 000
    K200941 000