FDAnews
www.fdanews.com/articles/75036-fda-clears-medstrat-pacs-system

FDA CLEARS MEDSTRAT PACS SYSTEM

August 4, 2005

MEDSTRAT has received 510(k) clearance from the FDA to market echoeSYSTEM, the company's patent-pending orthopedic Picture Archive Communication System (PACS) software.

The system -- which enables the communication, storage, viewing and manipulation of diagnostic medical images -- will be marketed with the Class II categorization by the FDA's Center for Devices and Radiological Health.

With the system, users can view patients' radiological studies on workstations locally and/or across computer networks, and orthopedic surgeons can securely access patient studies on echoeSYSTEM PACS servers locally on a practice's intranet or remotely via extranet or internet connections. The system also automates offsite data backup for disaster recovery of archives, simplifying Health Insurance Portability and Accountability Act conformance by practices, MEDSTRAT said.