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GE Senographe 2000D

This article was originally published in The Gray Sheet

Executive Summary

Full-field digital mammography system gains expanded FDA approval via PMA supplement for "soft copy" reading of digital patient images and diagnoses directly from a computer workstation, instead of traditional x-ray film. FDA had approved the original PMA for digital image review on film in February (1"The Gray Sheet" Feb. 7, 2000, p. 4). More than 35 of the devices have been installed in the U.S., with 60 installations expected by year-end. Worldwide, over 100 systems are in use
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