Compliance

Observance and regulatory at the highest level.

Our 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

Conformance
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:

ISO
13485-2016

Certificate

EN 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 TGA
Visage 7

Certificate

Australian TGA
Visage Ease Pro

Certificate

Visage Imaging, Inc.
12625 High Bluff Drive, Suite 205
San Diego, CA 92130

Phone: (858) 345-4410
Toll Free: (888) 998-4724