FDA 510(k) Clearance for Fujifilm’s Aspire Cristalle Breast Imaging Solution

Fujifilm Medical Systems U.S.A., Inc., has gained U.S. FDA 510(k) clearance for its Aspire Cristalle. Fujifilm Medical says Aspire Cristalle “resets the bar in digital mammography, combining innovative detector engineering with well thought out patient focused ergonomics, resulting in faster more confident diagnosis for clinicians and exceptional patient comfort.”

Background

Fujifilm Medical Systems U.S.A., Inc. claims to have the largest worldwide install base of digital mammography systems in the world. Its newly cleared Aspire Cristalle features advancements, including a patented Comfort Paddle, designed to make the most uncomfortable part of mammograms, more comfortable. The paddle’s unique soft edges, flexible composition and 4-way pivot contours to the individual shape of the breast to more comfortably apply compression for optimal tissue separation. The system also features new patient grip handles and padding for added stability and comfort, even soft backlighting and graphic mural decals to help ease patient anxiety and improved access for wheelchair exams, just to name a few.

Hexagonal Close Pattern (HCP) is an innovative detector pixel design, engineered to deliver higher acquisition efficiency, for finer detail, higher DQE, higher MTF and lower dose than conventional square pixel arrays. Engineered to produce brilliant images at low dose.

The system’s image quality is further enhanced with Fujifilm’s renowned image processing, iAEC automated exposure controls and ISC precisely tuned contrast, to intelligently adapt to the specific characteristics for every breast type and to image implants with ease.

Company comments

“Aspire Cristalle nicely represents our latest culmination of imaging innovation and attention to every detail in design,” said Rob Fabrizio, director of marketing and product development, Digital x-ray and Women’s Health, FUJIFILM Medical Systems U.S.A., Inc. “The Aspire Cristalle will deliver brilliant images with gentle dose, while redefining the patient experience through a notably more comfortable exam.”

Source: Fujifilm Medical Systems, U.S.A, Inc., Business Wire

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