Aspire Cristalle Mammography System Fujifilm Medical Systems USA FDA Approval

July 2, 2014 — Fujifilm Medical Systems U.S.A. Inc. announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) of the Aspire Cristalle mammography system. The Aspire Cristalle combines innovative detector engineering with well thought out patient focused ergonomics, resulting in faster more confident diagnosis for clinicians and exceptional patient comfort. First commercialized in Asia and Europe, the Aspire Cristalle has taken hold of customers' imagination and challenged the status quo in breast imaging technology across the globe.

The Aspire Cristalle brings an innovative solution to breast imaging customers around the world. New advancements include:

  • Patient experience enhancements, such as the patented Comfort Paddle, are designed to make the most uncomfortable part of mammograms, more comfortable. The paddle’s soft edges, flexible composition and four-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 a detector pixel design, engineered to deliver higher acquisition efficiency, for finer detail, higher DQE, higher MTF and lower dose than conventional square pixel arrays.
  • The system’s image quality is further enhanced with Fujifilm’s 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.

For more information: aspire.fujimed.com

 


Related Content

News | Breast Biopsy Systems

Feb. 18, 2026 — Mammotome, a Danaher company, has introduced the Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy ...

Time February 18, 2026
arrow
News | Breast Imaging

Feb. 16, 2026 — Rising demand for breast cancer screening and diagnostics is outpacing the supply of available breast ...

Time February 17, 2026
arrow
News | Magnetic Resonance Imaging (MRI)

Feb. 5, 2026 — Eyas Medical Imaging, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its ...

Time February 06, 2026
arrow
News | Ultrasound Women's Health

Feb. 5, 2026 — BrightHeart, a global provider of AI-driven prenatal ultrasound, has announced the availability of its B ...

Time February 05, 2026
arrow
News | Radiation Therapy

Feb. 4, 2026 — On World Cancer Day (02.04.26), the American Society for Radiation Oncology (ASTRO) and the European ...

Time February 04, 2026
arrow
News | Radiology Imaging

Feb. 4, 2026 — The Royal College of Radiologists (RCR) has issued its initial reaction to the British government's ...

Time February 04, 2026
arrow
News | FDA

Feb. 2, 2026 — Imagion Biosystems, Ltd. has submitted an Investigational New Drug (IND) application with the U.S. Food ...

Time February 02, 2026
arrow
News | Breast Imaging | Washington University

Jan. 22, 2026 — In breast cancer, a biopsy is the only diagnostic procedure that can determine if a suspicious lump or ...

Time January 29, 2026
arrow
News | Radiation Oncology

Jan. 27, 2026 — Researchers at the Icahn School of Medicine at Mount Sinai, in collaboration with other leading ...

Time January 29, 2026
arrow
News | Mammography

Jan. 16, 2026 — Vega Imaging Informatics has announced the successful curation of the world’s largest digital breast ...

Time January 19, 2026
arrow
Subscribe Now