IMS wins FDA approval for Giotto Image

Italian medical imaging vendor IMS has received 510(k) clearance for the newest version of its Giotto line of mammography units. Giotto Image has been redesigned with new mechanics and electronics, and a new compression device, according to the Bologna company.

Giotto Image retains the novel gantry design that distinguishes the Giotto line. The system’s x-ray tube and bucky are located in a circular gantry that can be rotated or tilted for additional positioning flexibility. The system can also be used for stereotactic biopsy exams with patients in the prone position, a feature not possible with conventional upright mammography units, according to Achille Albanese, marketing director at the company.

Giotto Image will be the platform for a full-field digital mammography (FFDM) system, called Giotto Image MD, that IMS is developing, according to Albanese. The detector will be based on amorphous selenium technology from Anrad, the digital x-ray subsidiary of Analogic of Peabody, MA. Resolution of the detector is 85 microns, with a detective quantum efficiency (DQE) of 40%, and modulation transfer function (MTF) of 52% at 5 line pairs/mm.

IMS displayed the system as a work-in-progress at the 2001 RSNA meeting, and displayed clinical images in the company’s booth. While earlier generations of Giotto systems have been displayed at previous RSNA meetings, this year’s meeting marks the start of a major push in the U.S. with Giotto Image. The company has signed on a distributor, MedX of Arlington Heights, IL, to sell the system.

By AuntMinnie.com staff writers
December 19, 2001

Related Reading

IMS begins Italian digital mammo trial, November 20, 2001

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