BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    StrokeSENS LVO

    DI: 00882916001025 · Model: v2.x · Circle Cardiovascular Imaging Inc
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    StrokeSENS LVO
    Primary DI
    00882916001025
    Version / Model
    v2.x
    Company Name
    Circle Cardiovascular Imaging Inc
    Labeler DUNS
    248028578
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-02-05
    Public Version
    3
    Public Version Date
    2025-12-05
    Public Version Status
    Update
    Public Device Record Key
    c61efdcd-dc21-4c46-8880-1733fb80c587

    Device Description

    StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected LVO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow. Notifications may include a compressed preview of images. StrokeSENS ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically registers images and uses an Atlas to segment and analyze ASPECTS Regions. StrokeSENS ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. The StrokeSENS device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of StrokeSENS are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QAS Radiological Computer-Assisted Triage And Notification Software
    POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

    GMDN Terms

    Code Name
    40867 CT system application software

    Identifiers

    Type ID
    Primary 00882916001025
    Previous B926SSSX10

    Premarket Submissions

    Submission Number Supplement Number
    K212261 000
    K250221 000