# K220497: CoLumbo

- Pathway: 510(k) (Traditional)
- Applicant: Smart Soft Healthcare AD
- Decided: Jun 23, 2022 after 121 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: 17 generations back to K971684 (1997). 193 ancestors in all.
6 later devices descend from it; 4 cite it directly.
5 of 200 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193290: AI-Rad Companion Brain MR, Siemens Medical Solutions USA, Inc. (2020) Summary page 4.

## Most influential descendants
- K241211: CoLumbo (2024), 2 descendants of its own
- K254015: CoLumbo C-Spine (2026), 0 descendants of its own
- K250367: CoLumboX (2025), 0 descendants of its own
- K242607: ScanDiags Ortho L-Spine MR-Q (2025), 0 descendants of its own
- K240793: MSKai (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K220497
Methodology: https://510kreport.com/methodology