# K250367: CoLumboX

- Pathway: 510(k) (Traditional)
- Applicant: Smart Soft Healthcare AD
- Decided: May 28, 2025 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
CoLumboX is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine radiograph x-ray images for users’ review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting measurements: ∙ Feature segmentation; ∙ Feature measurement; ∙ Threshold-based labeling of out-of-range measurement; and ∙ Export of measurement results. CoLumboX 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 x-ray images and potentially compile a report. The user is responsible for confirming/modifying settings, reviewing the software-generated measurements, and utilizing CoLumboX output using their medical judgment and discretion. The device is intended to be used only by hospitals and other medical institutions. Only DICOM x-ray images of patients aged 18 and older are considered to be valid input. CoLumboX does not support DICOM images of patients who are pregnant, or those with post-operative complications, tumors, or infections.

Source page: https://510kreport.com/device/K250367
Methodology: https://510kreport.com/methodology