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Sign in to claim this brandMedis Medical Imaging Systems bv
Netherlands·NL-MF-000002670
Last updated September 18, 2026
About
Cardiac imaging software solutions to support healthcare professionals in CT, MRI, X-Ray, and Ultrasound for over 30 years.
From the manufacturer's own website. Source
What Medis Medical Imaging Systems bv makes
The company develops analytical software for post-processing medical imaging studies, including quantitative coronary angiography (QCA), CT-based plaque analysis (CT-MASS), and vascular volume assessment (VVA) for X-ray, CT, and MRI. Additional offerings include magnetic resonance angiography (MRA) and coronary motion system (CMS) software, as well as tools for plaque quantification in MRI (QPLAQUE MR) and 3D coronary angiography (Qangio XA). The portfolio also covers MRI flow analysis, MRI magnetic resonance analytical software, and dedicated analytical packages for coronary ultrasound (QCU).
These products fall under EU Device Class II and Class IIa classifications, with regulatory listings in the EUDAMED database and FDA’s 510(k) premarket notification system. The manufacturer is based in the Netherlands.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- Netherlands
- Address
- 9, Schuttersveld, Leiden, Netherlands
- Website
- www.medisimaging.com
- —
- [email protected]
- Phone
- +31715241700
- PRRC Contact
- Bob Goedhart
- EUDAMED SRN
- NL-MF-000002670
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Quantitative Analysis Of Coronary Angiograms (qca) | K993763 | FDA 510(k) | Class II | Active |
| Ct-Mass | K033774 | FDA 510(k) | Class II | Active |
| X-Ray Vva | K112807 | FDA 510(k) | Class II | Active |
| Mra-Cms | K040746 | FDA 510(k) | Class II | Active |
| Quantitative Vascular Angiography - Cms | K023970 | FDA 510(k) | Class II | Active |
| Qplaque Mr | K073156 | FDA 510(k) | Class II | Active |
| Qangio XA 3D | K182611 | FDA 510(k) | Class II | Active |
| Mri- Flow Analytical Software Package | K994282 | FDA 510(k) | Class II | Active |
| Qcu Analytical Software Package | K011582 | FDA 510(k) | Class II | Active |
| Mr-Ct Vva | K140587 | FDA 510(k) | Class II | Active |
| Mri- Magnetic Resonance Analytical Software System | K994283 | FDA 510(k) | Class II | Active |
| Qangio Ct | K062386 | FDA 510(k) | Class II | Active |
| Quantitative Analysis Of Left Ventricular Angiograms (qlv) | K993765 | FDA 510(k) | Class II | Active |
| Rsa-Cms | K042383 | FDA 510(k) | Class II | Active |
| Cardiovascular Measurement System - View | K993761 | FDA 510(k) | Class II | Active |
| Ortho-Cms | K041162 | FDA 510(k) | Class II | Active |
| Qbrain | K050703 | FDA 510(k) | Class II | Active |
| Medis Suite MRCT | 20250203 | EUDAMED | Class IIa | Active |
| Medis Suite | 20240115 | EUDAMED | Class IIa | Active |
| Qfr | Medis QFR XA 2024 | EUDAMED | Class IIa | Active |
| Medis QFR XA | MEDISQFRXA | EUDAMED | Class IIa | Active |
| Qfr | Medis QFR XA 2022 | EUDAMED | Class IIa | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Medis Medical Imaging Systems, Inc. US