Fujifilm wins FDA nod for digital radiography suite

Fujifilm Medical Systems (TSE:4901) said today it won FDA 510(k) for its digital radiography FDR Visionary Suite and FDR Clinica X-ray components.

The new Visionary Suite X-ray system is designed for mid-to-large hospitals and health systems, while the FDR Clinica X-ray components were designed for outpatient facilities, FujiFilm 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,” strategic marketing director Rob Fabrizio said in a press release.

The FDR Visionary Suite is designed as a complete x-ray room system and allows for fully automated positioning with applications for tomosynthesis, energy subtraction and long length imaging.

In April, Fujifilm subsidiary VisualSonics said today it won FDA 510(k) clearance for its Vevo MD ultra high frequency clinical ultrasound system, the company’s 1st offering in the clinical market.

The Vevo MD is designed for image resolution down to 30 micrometers, and is compatible with FujiFilm VisualSonics UHF series of transducers capable of operating in a range of frequencies up to 70 Mhz.

The device was designed for use in a range of clinical fields, including neonatology, vascular, musculoskeletal, dermatology and other small parts within the 1st 3 cm of the body, FujiFilm said.

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