Radlink GPS Pro Imaging

Radlink GPS Pro Imaging is software that assists orthopedic surgeons in hip procedures by measuring the acetabulum's position relative to bone structures shown in radiological images. It overlays digital annotations on X-ray, CT, and C-arm images and provides measurement tools to support surgical planning and intraoperative guidance, though clinical judgment remains required and it is not for primary image interpretation.

The device uses geographic measurement and stitching technologies previously FDA-cleared, supports Windows operating systems, and includes DICOM transmission capabilities for hospital system integration. It requires minimal hardware specifications and maintains compatibility with C-Arm, X-Ray, and CT imaging modalities, with enhanced cybersecurity features compared to earlier predicate devices.

Not stated in this summary.

The subject device shares the same intended use as predicates CUPTIMIZE Advanced (K231503) and Radlink GPS (K142718)—preoperative templating and intraoperative surgical guidance for hip procedures using the same core geographic measurement and stitching technologies. Verification and validation testing including software performance, segmentation accuracy, usability evaluation, and cybersecurity assessment confirm equivalent safety and effectiveness, with enhancements (Windows-only support, improved cybersecurity) that do not raise new or different questions of safety.