Australian image management technology provider IMEXHS said its U.S. Food and Drug Administration (FDA) clearance has classified its Hiruko Essential PACS software package as a Class I medical device, allowing it to be marketed in the United States.
Hiruko Essential is a DICOM image and file manager that can capture, store, communicate, process, and display images and data within the system, as well as across computer networks at distributed locations using an embedded web-based viewer with basic image manipulation tools, according to the vendor. It can be deployed over a conventional TCP/IP network or cloud infrastructure using commercially available computer hardware platforms and operating systems, the company said.
IMEXHS said it is currently proceeding with a “soft launch” in the U.S. for Hiruko Essential and is working on a more detailed market entry plan. The vendor has so far signed with IGMC Medical Technology Group to distribute the software package and has won a 5.5-year software-as-a-service contract with Rad One, a Puerto Rico-based medical group.
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