# Medis Medical Imaging Systems BV

- Location (FDA's records): Leiden, NL
- FDA decisions: 19 (1994–2026): 19 510(k) clearances
- Names in FDA's records: Medis Medical Imaging Systems BV (18); Medis Medical Imaging Systems, Inc. (1)
- Product codes: LLZ (8), IZI (4), LNH (3), JAK (2), QHA (1), QIH (1)
- Predicates its devices cite: 29 (10 its own); citations of its devices by later devices: 53 (10 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Medical Systems: 3 (https://510kreport.com/company/ge-medical-systems)
- Vital Images, Inc.: 2 (https://510kreport.com/company/vital-images)
- Pie Medical Imaging BV: 2 (https://510kreport.com/company/pie-medical-imaging)
- Applicare Medical Imaging, B.V.: 2 (https://510kreport.com/company/applicare-medical-imaging)
- Tomtec Imaging Systems GmbH: 1 (https://510kreport.com/company/tomtec-imaging-systems)
- Insightful Corporation: 1 (https://510kreport.com/company/insightful)
- Cardiovascular Imaging Solutions, Ltd.: 1 (https://510kreport.com/company/cardiovascular-imaging-solutions)
- Omsbar, Ltd.: 1 (https://510kreport.com/company/omsbar)

## Firms that cite its devices most
- Pie Medical Imaging BV: 6 (https://510kreport.com/company/pie-medical-imaging)
- Sectra AB: 4 (https://510kreport.com/company/sectra)
- Paieon, Inc.: 3 (https://510kreport.com/company/paieon)
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Circle Cardiovascular Imaging, Inc.: 2 (https://510kreport.com/company/circle-cardiovascular-imaging)
- Medviso AB: 2 (https://510kreport.com/company/medviso)
- Indec Systems, Inc.: 2 (https://510kreport.com/company/indec-systems)
- Arterys, Inc.: 2 (https://510kreport.com/company/arterys)

## Its most-cited devices
- K140587: MR-CT Vva (2015), cited by 8
- K994283: Mri- Magnetic Resonance Analytical Software System (2000), cited by 8
- K994282: Mri- Flow Analytical Software Package (2000), cited by 7
- K993763: Quantitative Analysis of Coronary Angiograms (Qca) (1999), cited by 5
- K011582: Qcu Analytical Software Package (2001), cited by 4
- K993765: Quantitative Analysis of Left Ventricular Angiograms (QLV) (1999), cited by 4

## Recent decisions
- K260523: QGuideCT (1.0) (Oct 5, 2026)
- K182611: Qangio XA 3D (May 30, 2019)
- K140587: MR-CT Vva (Jan 6, 2015)
- K112807: X-Ray Vva (Feb 27, 2012)
- K073156: Qplaque MR (Mar 4, 2008)
- K062386: Qangio CT (Oct 5, 2006)
- K050703: Qbrain (Apr 21, 2005)
- K042383: Rsa-CMS (Oct 20, 2004)

Source page: https://510kreport.com/company/medis-medical-imaging-systems