CAD4TBBox

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Device Name

CAD4TBBox

Model / Reference

CAD4TBBox

Primary DI / UDI-DI

42624007200254, 04262400720056

Basic UDI-DI

426240072CAD4TBRC, 42640072CAD4TBV86K

EMDN Code

Z11039082 Various radiodiagnostic and interventional instruments - software accessories

Device Class

Class IIb

Medical Purpose

CAD4TB is a CE-certified AI software to support fast, easy, highly accurate automated TB detection with cost-efficiency. CAD4TB is available for online and offline use to analyse images 4 years old and above, enabling data-driven TB screening in resource-constrained settings.

CAD4TB is a medical device software that takes a single frontal chest radiograph from a subject of at least 4 years old as input, in the form of a DICOM image, and produces several outputs. These outputs include a score that is monotonically related to the likelihood that the radiograph shows abnormalities that are radiologically consistent with TB, a heat map that highlights these abnormalities, a score that is monotonically related to the likelihood that the radiograph corresponds to a bacteriologically confirmed TB case and the cardiothoracic ratio. Users can take these outputs into account in their clinical work and decide if the subject should go under further diagnostic testing for the presence of TB or further assessment based on the cardiothoracic ratio. It does not replace the role of the healthcare professional or of other diagnostic testing in the standard of care.

EUDAMED SRN

NL-PR-000033500