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FDA-cleared K254015

CoLumbo C-Spine

Smart Soft Healthcare AD

Authorized purpose: Post-process previously acquired cervical-spine MR images to segment vertebrae and disks, calculate quantitative measurements, label out-of-range values, and export results for user review and interpretation.

Modality
MRI
Anatomy
Cervical spine: vertebrae C3-C7 and disks C2C3 through C7T1
Decision
2026-04-01
FDA-cleared K250367

CoLumboX

Smart Soft Healthcare AD

Authorized purpose: Post-processing segmentation, measurement, threshold labeling, and export of quantitative lumbar-spine measurements to support clinical review; not diagnosis.

Modality
X-ray/Radiography
Anatomy
Lumbar spine, including vertebrae and sacrum
Decision
2025-05-28
FDA-cleared K220497

CoLumbo

Smart Soft Healthcare AD

Authorized purpose: 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 forconfirming/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.

Modality
MRI
Anatomy
Spine
Decision
2022-06-23