2

Organization name

Smart Soft Healthcare

SRN

BG-MF-000038728

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Bulgaria; available across 8 countries total.

Trade name

not provided

UDI-DI code

03800502388029

Basic UDI-DI

38005023882KH

Reference / catalog number

2

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

This device is not currently linked to any other device.

Certificate health across this manufacturer's portfolio.