CE, FDA, HIPAA, DICOM
At Shina Systems, all aspects of legal compliance are very important to us. Our customers, partners and employees can rest assured that Shina Systems makes every effort to meet and maintain compliance with all applicable industry and international standards.
Shina Systems declares that the 3Di platform meets the applicable provisions of both Council Directive 93/42/EEC concerning medical devices (including 2007/47/EC) and the FDA.
The 3Di platform meets HIPPA compliance requirements. 3Di system administrators can implement the internal regulations of the system in compliance with HIPAA requirements.
The following link leads to the DICOM Conformance Statements for Shina System's products. It is intended to provide the reader with knowledge of how to integrate products within a DICOM-compliant hospital network. They detail the DICOM Service Classes, Information Objects and Communication Protocols that are supported by the products. The information in these documents will facilitate compatibility checking.