Medis Medical Imaging Systems BV is one of 150 FDA 510(k) medical device manufacturers from Netherlands in the dataset, ranked by real submission volume.
Medis Medical Imaging Systems BV - FDA 510(k) Cleared Devices
Recent clearances: QGuideCT (1.0), Qangio XA 3D, MR-CT VVA
18
Total
18
Cleared
0
Denied
Medis Medical Imaging Systems BV has 18 FDA 510(k) cleared radiology devices. Based in Leiden, NL.
Latest FDA clearance: Oct 2026. Active since 1999.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Medis Medical Imaging Systems BV
18 devices
Cleared
Oct 05, 2026
QGuideCT (1.0)
Radiology
230d
Cleared
May 30, 2019
Qangio XA 3D
Radiology
251d
Cleared
Jan 06, 2015
MR-CT VVA
Radiology
305d
Cleared
Feb 27, 2012
X-RAY VVA
Radiology
153d
Cleared
Mar 04, 2008
QPLAQUE MR
Radiology
117d
Cleared
Oct 05, 2006
QANGIO CT
Radiology
51d
Cleared
Apr 21, 2005
QBRAIN
Radiology
34d
Cleared
Oct 20, 2004
RSA-CMS
Radiology
49d
Cleared
Jul 27, 2004
ORTHO-CMS
Radiology
85d
Cleared
Jun 08, 2004
MRA-CMS
Radiology
77d
Cleared
Mar 02, 2004
CT-MASS
Radiology
90d
Cleared
Jan 24, 2003
QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS
Radiology
56d
Cleared
Jul 31, 2001
QCU ANALYTICAL SOFTWARE PACKAGE
Radiology
69d
Cleared
Aug 30, 2000
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
Radiology
254d
Cleared
Mar 02, 2000
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
Radiology
73d
Cleared
Dec 28, 1999
CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW
Radiology
50d
Cleared
Nov 26, 1999
QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)
Radiology
18d
Cleared
Nov 26, 1999
QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)
Radiology
18d