Australian image management technology provider ImExHs said that its U.S. Food and Drug Administration (FDA) clearance has categorized its Hiroku Essential PACS software suite as a class I medical device, enabling it to be marketed in the U.S.
Hiroku Essential is a DICOM archive and image 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 conventional TCP/IP networking or cloud infrastructure using commercially available computer hardware platforms and operating systems, the company said.
ImExHs said it's currently proceeding with a "soft launch" in the U.S. for Hiroku Essential and is working on a more detailed market entry plan. The vendor has so far signed on IGMC Medical Technology Group to distribute the software suite and won a 5.5-year software-as-a-service contract from Rad One, a medical group in Puerto Rico.
