Visaris Americas wins FDA 510(k) for radiology and PACS suite

Digital imaging solutions company Visaris Americas said yesterday it won FDA 510(k) for its portfolio of software, flat panel detectors and various hardware offerings.

The company’s central Avanse technology is designed to integrate with latest-generation flat panel detectors, which Visaris said enables facilities to transition to a single software platform to reduce cost and training time.

“Visaris Americas was launched in October 2015 and is swiftly capturing industry attention as a disruptive provider of comprehensive, fully integrated digital solutions. The FDA clearance is an important step for Visaris Americas in providing a comprehensive digital imaging and workflow solution to a multi-tiered market segment. We are excited to be launching our new portfolio of digital radiography solutions to an international audience at the Radiological Society of North America conference being held in Chicago at the end of November. Our highly integrated digital acquisition software platform, Avanse, supports several advanced imaging capabilities typically cost prohibitive in some market segments and reserved for expensive DR devices,” digital sales & biz dev veep Rick Sbordone said in prepared remarks.

Visaris America’s Avanse software platform features full interoperability with both its own fully-integrated digital radiology systems, the company said.

The company is a collaborative effort between First Source and Visaris d.o.o., and plans on launching its full portfolio of products in the U.S. later this month.

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