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510(k) Data Aggregation
K Number
K233761Device Name
Orthopaedic Surgery Planning Software (AIJOINT)
Manufacturer
Longwood Valley Medical Ltd
Date Cleared
2024-08-05
(255 days)
Product Code
LLZ
Regulation Number
892.2050Why 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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