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
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Conformance
Statement
HL7
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Interface
Specification
IHE
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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
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Certificate
ISO
13485:2016
(under the MDSAP program)
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Certificate
FDA 21
CFR 892.2050
Visage PACS/CS
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Clearance
FDA 21
CFR 892.2050
Visage Ease Pro
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Clearance
FDA 21
CFR 892.2050
Visage Breast Density
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Clearance
European MDD
93/42/ECC Annex II
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Certificate
Canadian
MDR
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License
Australian TGA
Visage 7
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Certificate
Australian TGA
Visage Ease Pro
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Certificate
Australian TGA
Visage Breast Density
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Certificate
For E-labeling information, please click here.
Visage Imaging, Inc.
12625 High Bluff Drive, Suite 205
San Diego, CA 92130
Phone: (858) 345-4410
Toll Free: (888) 998-4724