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510(k) Data Aggregation

    K Number
    K233761
    Device Name
    Orthopaedic Surgery Planning Software (AIJOINT)
    Manufacturer
    Longwood Valley Medical Ltd
    Date Cleared
    2024-08-05

    (255 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Longwood Valley Medical Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is used in medical institutions, it can carry out 3D reconstruction, segmentation and semi-automatic identification of key points on CT images conforming to DICOM3.0 standard format, and assist physicians to overlay digital templates to assist surgeons with preoperative planning of adult hip and total knee replacement surgery. This product is intended for use by trained and qualified physicians and cannot be used as a basis for clinical diagnosis and treatment decisions alone.
    Device Description
    The proposed device, Orthopaedic Surgery Planning Software, is standalone software which is designed to help surgeons' specialists carry out the pre-operative planning for an adult hip and total knee replacement surgery for several surgical procedures, based on the patient's CT images. The Orthopaedic Surgery Planning Software can a carry out 3D reconstruction, segmentation and semi-automated identification of anatomical sites of CT images conforming to DICOM3.0 standard format, and assist physicians to simulate adult hip and total knee replacement surgery.
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