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Dual-Function Mammography and Prone Stereotactic Biopsy System Cleared for Distribution in US.
Las Vegas, NV, March 13, 2012 - Fischer Medical Technologies LLC (Fisher Medical), announces from the National Interdisciplinary Breast Center Conference that it has been named exclusive US distributor of Giotto's Full Field Digital Mammography (FFDM) systems.
After receiving 510(k) clearance by the FDA in November 2011 for the GIOTTO FFDM system, I.M.S. Srl (Internazionale Medico Scientifica) of Bologna, Italy and Fischer Medical of Broomfield, Colorado signed a multi-year distribution agreement. The newly formed Fischer-GIOTTO division is headed by Bob Rusk, who formerly managed Giotto USA.
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Giotto USA Receives 510K Clearance
Wichita, KS - November 1st, 2011 - Giotto USA yesterday announced the FDA clearance of a 510(k) application for the Giotto Image Digital Mammography Systems. The systems, the 3D with an 18 X 24 cm bucky and the 3DL with an 24 X 30 cm bucky, may now be marketed in the U.S. The milestone was announced by Giotto USA president Robert Rusk.
“This approval means that U.S. hospitals and clinics now have a true alternative mammography system for their patients,” said Rusk. “The Giotto is the only system which has a ring-shaped, tilting gantry that allows patient friendly “Face-to-Face positioning” and faster and easier positioning for technologists.”
Other unique features include: