In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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

Related Content




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts