Canon Medical Informatics A/S
Denmark DK-MF-000019622 Last updated 25 Oct 2026
- Devices
- 17
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
Vitrea Read Ref 8.5.0
Vitrea Read Ref 8.5.4
Vitrea Read Ref 8.5.5
Vitrea Read Ref 9.1.1
EasyViz Ref 8.3.9
Vitrea Read Ref 8.4.6
Vitrea Read Ref 8.4.4
Vitrea Read Ref 8.5.1
Vitrea Read Ref 8.4.2
Vitrea Read Ref 8.5.7
Vitrea Read Ref 9.0.1
Vitrea Read Ref 8.5.3
Vitrea Read Ref 8.5.6
Vitrea Read Ref 8.4.3
Vitrea Read Ref 9.1.2
Vitrea Read Ref 9.0.0
Vitrea Read Ref 8.4.5
EUDAMED certificates
Intertek Medical Notified Body AB 2862 1 certificate
- 28620128868 Issued
Quality management system EU MDR
- Issued
- 30 Sep 2022
- Expires
- 23 Apr 2027
Related companies
Notified bodies
FDA establishments
- Canon Medical Informatics A/S US
What Canon Medical Informatics A/S makes
Canon Medical Informatics A/S develops post-processing software for radiology imaging, including tools for advanced visualization and analysis of CT, MRI, and other medical scans. The portfolio includes platforms like Vitrea Read, designed for diagnostic interpretation and workflow optimization in clinical settings, as well as EasyViz for enhanced image rendering and measurement.
The company’s devices fall under EU Class IIa medical devices and are registered in the EUDAMED database. The portfolio is regulated under EU Medical Device Regulations (MDR). Canon Medical Informatics A/S is headquartered in Denmark.
Frequently asked questions
What types of medical devices does Canon Medical Informatics A/S manufacture?
Canon Medical Informatics A/S specializes in post-processing software for radiology imaging. Their devices focus on advanced visualization and analysis tools for CT, MRI, and other medical scans. Examples include platforms like Vitrea Read, which aids in diagnostic interpretation and workflow optimization, and EasyViz, which enhances image rendering and measurement capabilities.
Where is Canon Medical Informatics A/S based?
Canon Medical Informatics A/S is headquartered in Denmark. The company’s location influences its regulatory compliance with EU-specific requirements, such as those under the EU Medical Device Regulations (MDR).
Which regulatory registries list Canon Medical Informatics A/S devices?
Canon Medical Informatics A/S devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices under the EU Medical Device Regulations (MDR).
How are Canon Medical Informatics A/S devices classified under EU regulations?
All devices produced by Canon Medical Informatics A/S fall under the EU Class IIa category. This classification is determined based on the risk associated with the device’s intended use, where Class IIa represents a moderate risk level requiring additional scrutiny and compliance measures under the EU Medical Device Regulations (MDR).
What is the primary purpose of the software developed by Canon Medical Informatics A/S?
The primary purpose of Canon Medical Informatics A/S software is to enhance diagnostic workflows in radiology by providing advanced visualization and analysis tools. These tools are designed to improve the accuracy and efficiency of interpreting medical scans, such as CT and MRI images, for clinical decision-making.
Information
- Country
- Denmark
- Address
- 4, Krumtappen , Valby, Denmark
- Website
- mi.medical.canon
- [email protected]
- PRRC contact
- Martin de Bruin
- EUDAMED SRN
- DK-MF-000019622
- FDA FEI number
- 3006619220