Medis Suite MRCT

Model / Reference

20260908

Primary DI / UDI-DI

B141MEDISSUITEMRCT2026

Basic UDI-DI

B-B141MEDISSUITEMRCT2026

EMDN Code

Z11030592 Radiology instruments - medical device software

Device Class

Class IIa

Special Device Type

-1192

Market of Registration

Netherlands

EUDAMED SRN

NL-MF-000002670

• Qfr

  Class IIa

  CE/MDR

• QGuideCT (1.0)

  Class II

  FDA 510(k) K260523 Active Cleared 5 Oct 2026

• Quantitative Analysis of Coronary Angiograms (Qca)

  Class II

  FDA 510(k) K993763 Active Cleared 26 Nov 1999

• CT-Mass

  Class II

  FDA 510(k) K033774 Active Cleared 2 Mar 2004

• X-Ray Vva

  Class II

  FDA 510(k) K112807 Active Cleared 27 Feb 2012

• Mra-Cms

  Class II

  FDA 510(k) K040746 Active Cleared 8 Jun 2004

See all devices from Medis Medical Imaging Systems bv →