Standards Commitment

All Visage Imaging products are based on open standards like DICOM and HL7 in order to provide the best possible interoperability with imaging informatics and healthcare information systems, such as, but not limited to, RIS, PACS, EHR, VNA, Workflow Platforms, Analytics Platforms and Reporting Systems.  In our experience, commitment to open standards results in proven, reliable integration.

Visage Imaging also supports the Integrating the Healthcare Enterprise (IHE) initiative and is certified for numerous integration profiles.

DICOM [ Conformance Statement ]
HL7 [ Interface Specification ]
IHE [ Integration Statement ]

Quality System and Product Quality

All processes at Visage Imaging are oriented towards maintaining superior product and service quality for the benefit of our global customers.  Internal and external audits guarantee continuous monitoring and improvement of our quality management system.  Consistent with our company philosophy, all of our employees are challenged on an ongoing basis to contribute to the continuous improvement of our products, services, and processes.

Our customers can rely on Visage Imaging complying with the relevant international quality standards – confirmed every year through certified regulatory bodies.  Our quality management system complies with:

+ EN ISO 13485:2016 [ Certificate ]
+ ISO 13485:2016 (under the MDSAP program) [ Certificate ]

In addition to these international certifications, the Visage product line has received 510(k) clearance to market from the FDA and is also registered as medical device in Europe, Canada and Australia:

FDA 21 CFR 892.2050 – Visage PACS/CS  [ Clearance ]
FDA 21 CFR 892.2050 – Visage Ease Pro  [ Clearance ]
European MDD 93/42/ECC, Annex II  [ Certificate ]
Canadian MDR  [ License ]
Australian RTG – Visage 7 [ Certificate ]
+ Australian RTG – Visage Ease Pro [ Certificate ]
Australian RTG – Visage Breast Density [ Certificate ]

This underscores our dedication to manufacturing, marketing, and supporting only the highest quality products and medical devices for the global market.