Fujifilm gets FDA 510(k) clearance for FDR Visionary Suite

3 August 2016 (Last Updated August 3rd, 2016 18:30)

Fujifilm Medical Systems USA has secured the US Food and Drug Administration (FDA) 510(k) clearance for its FDR Visionary Suite and has introduced its FDR Clinica X-Ray Components.

Fujifilm Medical Systems USA has secured the US Food and Drug Administration (FDA) 510(k) clearance for its FDR Visionary Suite and has introduced its FDR Clinica X-Ray Components.

The FDR Visionary Suite is the latest complete x-ray room system which has been designed to optimise imaging workflow and enhance the clinical capabilities to support complex exams and diagnosis.

The fully automated system features flexibility in its mechanism providing a range of advanced applications such as omosynthesis, energy subtraction, and long-length imaging which are easy to use.

"These newly-released innovations are welcomed additions to our full portfolio of DR room offerings and meet the exacting standards in performance the market has come to expect from Fujifilm."

It is fitted with Fujifilm’s advanced cesium iodide (CsI) detectors and image processing which results to an improved positioning repeatability and optimise image quality and diagnostic visibility.

Fujifilm’s FDR Clinica X-ray Components are designed to promote improved workflow and thereby an improved patient care using its high-quality, cost-effective digital x-ray solutions.

The FDR Clinica X-ray Components’ flexible mechanism offers a range of power ratings making it suitable to facility’s specific requirements such as a medium-sized x-ray department, unstable power supply and a large facility that requires a rigorous workload.

Other features include a time-saving rotating bucky tray, which reduces detector handling; an automatic detector connection improving efficiency and eliminating cable clutter and an optional tilting wall stand to allow the patient to be imaged while being seated.

Fujifilm Medical Systems US digital radiography and women’s health strategic marketing director Rob Fabrizio said: “We take great pride in our ability to develop digital radiography solutions that uniquely benefit patient outcomes, technologist productivity, enhanced patient safety and bring maximum ROI.

“These newly-released innovations are welcomed additions to our full portfolio of DR room offerings and meet the exacting standards in performance the market has come to expect from Fujifilm.”

The FDR Visionary Suite will cater to mid-to-large sized healthcare facilities while the FDR Clinica X-ray Components are suited for active outpatient facilities.