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Medis Medical Imaging Systems BV

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K182611Qangio XA 3DMay 30, 2019
K140587MR-CT VVAJanuary 6, 2015
K112807X-RAY VVAFebruary 27, 2012
K073156QPLAQUE MRMarch 4, 2008
K062386QANGIO CTOctober 5, 2006
K050703QBRAINApril 21, 2005
K042383RSA-CMSOctober 20, 2004
K041162ORTHO-CMSJuly 27, 2004
K040746MRA-CMSJune 8, 2004
K033774CT-MASSMarch 2, 2004
K023970QUANTITATIVE VASCULAR ANGIOGRAPHY - CMSJanuary 24, 2003
K011582QCU ANALYTICAL SOFTWARE PACKAGEJuly 31, 2001
K994283MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEMAugust 30, 2000
K994282MRI- FLOW ANALYTICAL SOFTWARE PACKAGEMarch 2, 2000
K993761CARDIOVASCULAR MEASUREMENT SYSTEM - VIEWDecember 28, 1999
K993763QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)November 26, 1999
K993765QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)November 26, 1999
K940172CARDIOVASCULAR MEASUREMENT SYSTEM-CMSSeptember 29, 1994