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

    Cirrus Resting State fMRI Software

    K Number: K251009 · Decision Jun 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    303
    Applicant Total
    1
    Review Days
    66

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Cirrus Resting State fMRI Software
    K Number
    K251009
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sora Neuroscience, Inc.
    Date Received
    April 1, 2025
    Decision Date
    June 6, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QIH), ordered by most recent decision date.

    Synapse PACS (7.6.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    WatchMate Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    MediAI-OA

    FDA 510(k)
    FDA Class 2 ·Radiology

    LungMaps

    FDA 510(k)
    FDA Class 2 ·Radiology

    Brainomix 360 Hyperdensity

    FDA 510(k)
    FDA Class 2 ·Radiology

    Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all