CoLumbo

Primary DI

03800502388029

Basic UDI-DI Code

38005023882KH

Reference

2

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Smart Soft Healthcare

CoLumbo is a medical device (software) for viewing and interpreting magnetic resonance imaging (MRI) of the lumbar spine. The software is an assistive tool that helps radiologists to identify and measure lumbar spine abnormalities in medical images and record their observations in a report. The software helps to streamline the review by highlighting features of the anatomy that may warrant the radiologist’s attention and scrutiny. Color-coded annotations assist the radiologist with visualizing measurements of specific features in the imaging characteristic of pathology. The radiologist then confirms whether these features represent a true abnormality versus a spurious finding, such as an artifact or normal variation of the anatomy. The findings are classified using “modifiers” based on thresholds set by each software user and stored in the user’s individualized software settings. The user also identifies and classifies findings and observations that the software may not annotate.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).