LAIA XR

LAIA XR is a software device for displaying and visualizing 3D medical images from CT and MR scans (DICOM format) to support pre-operative surgical planning. It runs on standard computers or optional VR headsets and provides tools for image manipulation, measurement, fiducial marking, and surgical planning documentation. Images viewed through HMD or PC monitor are for informational purposes only, not diagnostic use.

LAIA XR supports CT and MR imaging modalities with DICOM input; the predicate supports CT, Angio CT, MRI, CBCT, PET, and SPECT. Both provide MPR viewing, 3D volume rendering with customizable transfer functions, quantitative measurements, fiducial placement, and surgical planning documentation. LAIA XR uses wired network transmission with HTTPS/SSL encryption; predicate uses wireless encrypted transmission. LAIA XR includes help tooltips and crosshair synchronization across multiple views, which the predicate lacks.

Not stated in this summary.

LAIA XR is substantially equivalent to predicate VSI HoloMedicine (K213215) because both are Class II medical image management systems under 21 CFR 892.2050 with the same product code (LLZ). They share the same regulatory classification, intended use (pre-operative planning visualization), intended users (qualified healthcare professionals), and core functional capabilities (3D visualization, surgical planning tools, image manipulation). Differences in imaging modalities, transmission modes, and specific features were determined to have no impact on safety, performance, or efficacy.