Hologic Selenia
This article was originally published in The Gray Sheet
Executive Summary
American College of Radiology is authorized to accredit facilities that use the full-field digital mammography systems, effective Sept. 15. Prior to FDA sign-off for ACR accreditation, facilities using the device had to file directly with the agency for an MQSA certification extension to include the system and have a back-up screen-film. The device debuted earlier this year. ACR already has accreditation authority for Fischer's SenoScan and GE Medical Systems' Senographe 2000D FFDM systems (1"The Gray Sheet" Aug. 11, 2003, p. 19)...
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