Has SonicDICOM PACS received approval from the FDA, CE or any other organizations?

No, SonicDICOM PACS has not received any approval yet.
Therefore, our software cannot be used for a diagnosis purpose in countries or regions where need approvals to use it for diagnosis.
We are currently planning to receive Japanese pharmaceutical approval in 2016.
Also we are currently gathering information about obtaining FDA and CE, besides information about being HIPAA and HITECH compliant.