Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Medis Medical Imaging Systems BV · Predicate Candidate Screening

17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

73 daysmedian FDA review time
254 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182611Qangio XA 3DMedis Medical Imaging Systems BV2019-05-302510
K140587MR-CT VVAMedis Medical Imaging Systems BV2015-01-063050
K112807X-RAY VVAMedis Medical Imaging Systems BV2012-02-271530
K073156QPLAQUE MRMedis Medical Imaging Systems BV2008-03-041170
K062386QANGIO CTMedis Medical Imaging Systems BV2006-10-05510
K050703QBRAINMedis Medical Imaging Systems BV2005-04-21340
K042383RSA-CMSMedis Medical Imaging Systems BV2004-10-20490
K041162ORTHO-CMSMedis Medical Imaging Systems BV2004-07-27850
K040746MRA-CMSMedis Medical Imaging Systems BV2004-06-08770
K033774CT-MASSMedis Medical Imaging Systems BV2004-03-02900
K023970QUANTITATIVE VASCULAR ANGIOGRAPHY - CMSMedis Medical Imaging Systems BV2003-01-24560
K011582QCU ANALYTICAL SOFTWARE PACKAGEMedis Medical Imaging Systems BV2001-07-31690
K994283MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEMMedis Medical Imaging Systems BV2000-08-302540
K994282MRI- FLOW ANALYTICAL SOFTWARE PACKAGEMedis Medical Imaging Systems BV2000-03-02730
K993761CARDIOVASCULAR MEASUREMENT SYSTEM - VIEWMedis Medical Imaging Systems BV1999-12-28500
K993765QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)Medis Medical Imaging Systems BV1999-11-26180
K993763QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)Medis Medical Imaging Systems BV1999-11-26180

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda