Data / Medical devices / Netherlands / Medis Medical Imaging Systems, B.V.
Medis Medical Imaging Systems, B.V.: FDA-registered device maker in LEIDEN Zuid-Holland, Netherlands, 4 510(k) clearances
Medis Medical Imaging Systems, B.V. is registered with the FDA (registration 9614587) in LEIDEN Zuid-Holland, Netherlands. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 30, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614587
- FEI number
- 3006974930
- Address
- Schuttersveld 9, LEIDEN Zuid-Holland, Netherlands, 2316 XG
- Owner or operator
- MEDIS HOLDING B.V. (9039556)
- Roles
- Manufacturer
- First device listed
- November 22, 2005
- Registered through
- 2026
- Brand names listed
- 3DView, Medis Suite, Medis Suite MRCT, QAngio XA, QAngio XA 3D, QCU-CMS, QFlow, QFlow 4D and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | QHA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2019 | K182611 | Qangio XA 3D | QHA | Substantially Equivalent | Medis Medical Imaging Systems BV | accessdata.fda.gov |
| January 6, 2015 | K140587 | MR-CT VVA | LLZ | Substantially Equivalent | Medis Medical Imaging Systems BV | accessdata.fda.gov |
| February 27, 2012 | K112807 | X-RAY VVA | LLZ | Substantially Equivalent | Medis Medical Imaging Systems BV | accessdata.fda.gov |
| July 31, 2001 | K011582 | QCU ANALYTICAL SOFTWARE PACKAGE | LLZ | Substantially Equivalent | Medis Medical Imaging Systems BV | accessdata.fda.gov |
Compare with other makers
- All makers of X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
- All makers of System, Image Processing, Radiological
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated May 30, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.