510(k) Report

FDA applicant

Medis Medical Imaging Systems BV

Leiden, NL19 decisions1994–20260 recalls

FDA records 19 decisions for Medis Medical Imaging Systems BV (Leiden, NL) from 1994 to 2026: 19 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and IZI (System, X-Ray, Angiographic). Its devices cite 29 predicates, 10 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medis Medical Imaging Systems, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Medis Medical Imaging Systems BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2008: 12012: 12015: 12019: 12026 (partial year): 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medis Medical Imaging Systems BV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medis Medical Imaging Systems BV’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological8decisions
  • IZISystem, X-Ray, Angiographic4decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging3decisions
  • JAKSystem, X-Ray, Tomography, Computed2decisions
  • QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device1decision
  • QIHAutomated Radiological Image Processing Software1decision

Whose devices does it build on?

Its devices cite 29 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 53 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K140587MR-CT VvaMedis Medical Imaging Systems BV · 20158cite it
  • K994283Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 20008cite it
  • K994282Mri- Flow Analytical Software PackageMedis Medical Imaging Systems BV · 20007cite it
  • K993763Quantitative Analysis of Coronary Angiograms (Qca)Medis Medical Imaging Systems BV · 19995cite it
  • K011582Qcu Analytical Software PackageMedis Medical Imaging Systems BV · 20014cite it
  • K993765Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 19994cite it

What has FDA decided for it lately?

  • K260523QGuideCT (1.0)Medis Medical Imaging Systems BV · 2026
  • K182611Qangio XA 3DMedis Medical Imaging Systems BV · 2019
  • K140587MR-CT VvaMedis Medical Imaging Systems BV · 2015
  • K112807X-Ray VvaMedis Medical Imaging Systems BV · 2012
  • K073156Qplaque MRMedis Medical Imaging Systems BV · 2008
  • K062386Qangio CTMedis Medical Imaging Systems BV · 2006
  • K050703QbrainMedis Medical Imaging Systems BV · 2005
  • K042383Rsa-CMSMedis Medical Imaging Systems BV · 2004

All 18 as Medis Medical Imaging Systems BV →The one decision as Medis Medical Imaging Systems, Inc. →