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Portable PACS with CAD4TB

by Delft Imaging Systems B.V. EUDAMED

Active European Union EUDAMED: not on the EU market

Ref Portable PACS with CAD4TB

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426240072PACSCAD4TBEK Basic UDI-DIDate26 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

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

Specification

EUDAMED

Model / Reference
Portable PACS with CAD4TB
Primary DI / UDI-DI
42624007200322
Basic UDI-DI
426240072PACSCAD4TBEK
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 for 4 years old and above, enabling data-driven TB screening in resource-constrained settings. [EN]

Manufacturer details

EUDAMED SRN
NL-PR-000033500

Other devices from Delft Imaging Systems B.V.

Properties

Other properties (1)

  • Sterile: No