CoLumbo
CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously‑acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting out‑of‑range measurements:
- Feature segmentation;
- Feature measurement;
- Threshold-based labeling of out‑of‑range measurement; and
- Export of measurement results to a written report for user's review, revise and approval.
CoLumbo does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to more easily identify and classify features in lumbar MR images and compile a report. The user is responsible for confirming/modifying settings, reviewing and verifying the software-generated measurements, inspecting out-of-range measurements, and approving draft report content using their medical judgment and discretion. The device is intended to be used only by hospitals and other medical institutions. Only DICOM images of MRI acquired from lumbar spine exams of patients aged 18 and above are considered to be valid input. CoLumbo does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, or have post-operational complications, scoliosis, tumors, infections, fractures
FDA 510(k): K220497
HC_4404_August2024
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