BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Viz Subdural+, Viz SUBDURAL PLUS

    K Number: K250354 · Decision Jun 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    303
    Applicant Total
    11
    Review Days
    123

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    Basic Information

    Device Name
    Viz Subdural+, Viz SUBDURAL PLUS
    K Number
    K250354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Viz. Ai, Inc.
    Date Received
    February 7, 2025
    Decision Date
    June 10, 2025
    Product Code
    QIH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QIH Automated Radiological Image Processing Software

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    Other Clearances by Viz. Ai, Inc.

    K Number Device Name
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    K223042 Viz LVO ContaCT
    K221100 Viz RV/LV
    K220439 Viz SDH
    K213319 Viz ANEURYSM, Viz ANX
    K210209 Viz ICH
    K193658 Viz ICH
    K180161 Viz CTP
    Search all 11 clearances from Viz. Ai, Inc. →