Smart Soft Healthcare AD radiology AI products

FDA-cleared K254015

CoLumbo C-Spine

Smart Soft Healthcare AD

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...

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

MSK and bone Quantification and segmentation

FDA-cleared K250367

CoLumboX

Smart Soft Healthcare AD

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

MSK and bone Quantification and segmentation

FDA-cleared K220497

CoLumbo

Smart Soft Healthcare AD

CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR)...

Modality: MRI
Anatomy: Spine
Decision: 2022-06-23

MSK and bone Oncology quantification Quantification and segmentation