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Digital mammography system receives final FDA approval.(Food and Drug Administration)(Brief Article)
2002 NOV 14 - (NewsRx.com & NewsRx.net) -- Hologic, Inc., (HOLX), a provider of women's diagnostic imaging systems and digital radiography systems, announced it received final approval from the U.S. Food and Drug Administration (FDA) for a premarket approval (PMA) supplement which covers the use of the company's proprietary DirectRay amorphous-selenium, direct-to-digital image receptor for its LORAD Selenia Full Field Digital Mammography (FFDM) System.
The Selenia generates digital mammographic images that can be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammographic images can be interpreted on either hard copy film or the ...
- Food and Drug Administration (FDA) Approves the American College of Radiology...
- Press release article from: PR Newswire September 16, 2003 700+ words
...body for Lorad Selenia full field digital mammography systems. Hologic is a leading provider...facilities purchasing the full field digital mammography system will go directly to the ACR...planning to convert to an all-digital mammography environment. Since Hologic began...
- Emageon Attains Market Clearance for Diagnostic Viewing of Digital Mammography.
- Press release article from: PR Newswire October 25, 2004 700+ words
...medical systems, announced today that it has received market clearance for softcopy viewing of digital mammography from the Food and Drug Administration (FDA). This clearance specifically relates to Emageon's UltraVisual advanced visualization...
- No Evidence That Digital Mammography Provides Additional Benefit Over Screen...
- Press release article from: PR Newswire June 11, 2003 700+ words
...insufficient data to prove that digital mammography is superior to standard...available evidence regarding digital mammography was done by a panel...the U.S. Food and Drug Administration approved digital mammography for clinical use, it...
- Fischer Imaging Delivers First Commercial SenoScan Digital Mammography System...
- Press release article from: PR Newswire October 2, 2001 700+ words
...manufacturing of digital mammography and medical imaging...SenoScan Full Field Digital Mammography Systems to participants...by the Food and Drug Administration, (FDA), the SenoScan Full Field Digital Mammography System, is set...
- Quest International Announces FDA 510(k) Clearance for New ME551i2 5MP...
- Press release article from: PR Newswire August 28, 2006 700+ words
...approval by the U.S. Food and Drug Administration for use in all digital mammography applications. The ME551i2 is a 21...critical applications such as Flat Field Digital Mammography (FFDM), this can make the difference...
- Digital mammography system coming.
- Magazine article from: Healthcare Purchasing News March 1, 2000 700+ words
The Food and Drug Administration has approved the first digital mammography system. An agency official cautioned that the GE Medical Senographe 2000D system is not yet proven to be better at diagnosing...
- Digital mammography system OK'd by FDA.(Brief Article)
- Magazine article from: Modern Healthcare Hensley, Scott February 21, 2000 700+ words
...to win Food and Drug Administration approval to sell a general purpose digital mammography system. The high...slow to approve digital mammography systems. It rebuffed...Nevertheless, the digital mammography system will allow...
- Fischer Imaging Receives Final FDA Approval for Its SenoScan Full Field Digital...
- Press release article from: PR Newswire September 25, 2001 700+ words
...manufacturing of digital mammography and medical imaging...final Food and Drug Administration (FDA) approval...SenoScan Full Field Digital Mammography System. Louis...SenoScan Full Field Digital Mammography System presents...