Company ยท NL
Medis Medical Imaging Systems BV
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2026. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLZ | System, Image Processing, Radiological | 8 |
| IZI | System, X-Ray, Angiographic | 4 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 3 |
| JAK | System, X-Ray, Tomography, Computed | 2 |
| QHA | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | 1 |
| QIH | Automated Radiological Image Processing Software | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 5, 2026 | K260523 | QGuideCT (1.0) Medis Medical Imaging Systems BV, NL | QIH |
| May 30, 2019 | K182611 | Qangio XA 3D Medis Medical Imaging Systems BV, NL | QHA |
| Jan 6, 2015 | K140587 | MR-CT VVA Medis Medical Imaging Systems BV, NL | LLZ |
| Feb 27, 2012 | K112807 | X-RAY VVA Medis Medical Imaging Systems BV, NL | LLZ |
| Mar 4, 2008 | K073156 | QPLAQUE MR Medis Medical Imaging Systems BV, NL | LNH |
| Oct 5, 2006 | K062386 | QANGIO CT Medis Medical Imaging Systems BV, NL | JAK |
| Apr 21, 2005 | K050703 | QBRAIN Medis Medical Imaging Systems BV, NL | LLZ |
| Oct 20, 2004 | K042383 | RSA-CMS Medis Medical Imaging Systems BV, NL | LLZ |
| Jul 27, 2004 | K041162 | ORTHO-CMS Medis Medical Imaging Systems BV, NL | LLZ |
| Jun 8, 2004 | K040746 | MRA-CMS Medis Medical Imaging Systems BV, NL | LLZ |
| Mar 2, 2004 | K033774 | CT-MASS Medis Medical Imaging Systems BV, NL | JAK |
| Jan 24, 2003 | K023970 | QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS Medis Medical Imaging Systems BV, NL | IZI |
| Jul 31, 2001 | K011582 | QCU ANALYTICAL SOFTWARE PACKAGE Medis Medical Imaging Systems BV, NL | LLZ |
| Aug 30, 2000 | K994283 | MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM Medis Medical Imaging Systems BV, NL | LNH |
| Mar 2, 2000 | K994282 | MRI- FLOW ANALYTICAL SOFTWARE PACKAGE Medis Medical Imaging Systems BV, NL | LNH |
| Dec 28, 1999 | K993761 | CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW Medis Medical Imaging Systems BV | LLZ |
| Nov 26, 1999 | K993765 | QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV) Medis Medical Imaging Systems BV | IZI |
| Nov 26, 1999 | K993763 | QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) Medis Medical Imaging Systems BV | IZI |
| Sep 29, 1994 | K940172 | CARDIOVASCULAR MEASUREMENT SYSTEM-CMS Medis Medical Imaging Systems, Inc. | IZI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||