# K254015: CoLumbo C-Spine

- Pathway: 510(k) (Traditional)
- Applicant: Smart Soft Healthcare AD
- Decided: Apr 1, 2026 after 107 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K971684 (1997). 195 ancestors in all.
No later device cites it as a predicate yet.
5 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241211: CoLumbo, Smart Soft Healthcare (2024) Summary page 5.

## Indications for use
CoLumbo C-Spine is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM cervical 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: • Segmentation of the vertebrae (C3-C7) and disks (C2C3-C7T1); • Measurements based on the segmentation; • Threshold-based labeling of out-of-range measurement; and • Export of measurement results. CoLumbo C-Spine does not produce or recommend any type of medical diagnosis or treatment. The device outputs are intended to be a starting point for a clinical workflow and should not be interpreted or used as a diagnosis. Instead, CoLumbo C-Spine simply helps users to more easily identify and classify features in cervical MR images and potentially compile a report. The user is responsible for confirming/modifying settings, reviewing the software-generated measurements, utilizing CoLumbo C-Spine's output using their medical judgment and discretion. The device is intended to be used only by hospitals and other medical institutions. Only DICOM MR images of the spine of patients aged 22 and above with adequate visualization of C2–C7 are considered to be valid input. Performance has not been established in the presence of vertebral enumeration variants that may interfere with reliable vertebral counting, including true cervical ribs, hemivertebrae, congenital or acquired vertebral fusion, for images acquired with contrast media, for cases involving tumors, infections, post-operative changes, or vertebral fusion, or for examinations in which the C2 vertebra is not adequately visualized.

Source page: https://510kreport.com/device/K254015
Methodology: https://510kreport.com/methodology