Radlink GPS Pro Imaging
Radlink, Inc.Radlink GPS Pro Imaging is an advanced image processing software that assists orthopedic surgeons in hip procedures by measuring the acetabulum’s position relative to bone structures seen in radiological images. The software overlays digital annotations on images and offers measurement tools to help surgeons plan and execute hip, knee, and trauma component positioning more precisely, improving procedural accuracy and outcomes.
Intended Use
Radlink GPS Pro Imaging is an image-processing software intended to assist in hip procedures by measuring the acetabulum’s position relative to local bone structures identified from radiological images. It allows overlaying digital annotations and performing measurements on images.
Technology
The software leverages advanced geographic measurement and stitching technologies to ensure precise and reliable image handling. It supports full image acquisition and DICOM transmission, integrating with hospital systems and running on Windows OS with minimal hardware requirements.
Performance
Comprehensive cybersecurity testing and software verification/validation were performed in line with FDA guidance and standards. Verification included software performance, segmentation accuracy, usability, and cybersecurity assessments, confirming safety and effectiveness equivalent to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/24/2024
7 months - 2
FDA Approval
3/18/2025
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