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

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

    K Number: K252103 · Decision Dec 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    303
    Applicant Total
    5
    Review Days
    152

    Basic Information

    Device Name
    Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
    K Number
    K252103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mighty Oak Medical
    Date Received
    July 3, 2025
    Decision Date
    December 2, 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

    Other Clearances by Mighty Oak Medical

    K Number Device Name
    K260322 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
    K253472 FIREFLY® Pedicle Screw Navigation Guide
    K251532 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
    K234009 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)