FDA: Page 33

Siemens, Fuji join forces in mammography
By AuntMinnie.com staff writers
December 6, 2000
CT laser mammography system nears European approval
By AuntMinnie.com staff writers
December 5, 2000
Final 510(k) approvals for November 2000
Issued December 5, 2000
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for November 2000.
December 4, 2000
Fischer prepares for SenoScan launch with CADx deal
By Brian Casey
CHICAGO - Mammography developer Fischer Imaging is laying the groundwork for the commercial launch of its SenoScan full-field digital mammography system. The Denver company yesterday announced a technology collaboration with computer-aided diagnosis firm CADx Medical Systems of Laval, Quebec.
November 28, 2000
Final 510(k) approvals for October 2000
Issued November 7, 2000
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for October 2000.
November 5, 2000
Final PMA approvals for October 2000
Issued November 7, 2000
Each month the U.S. food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions from the previous month. The following decisions were rendered for October 2000.
October 12, 2000
Final PMA approvals for September, 2000
Issued October 12, 2000
Each month the U.S. food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions from the previous month. The following decisions were rendered for September 2000.
October 11, 2000
Final 510(k) approvals for September 2000
Issued October 5, 2000
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for September, 2000.
October 5, 2000
CDRH announces advisory meeting on Nov. 6, 2000
Issued September 28, 2000
The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) will hold a public meeting on November 6, 2000 in Gaithersburg, MD, U.S. The Radiological Devices Panel of the Medical Devices Advisory Committee will discuss, make recommendations, and vote on a premarket approval application for an embolic radiation therapy device.
September 27, 2000
FDA approves OSI ultrasound scanner to assess fracture risk
By AuntMinnie.com staff writers
September 25, 2000
Final 510(k) approvals for August 2000
Issued September 5, 2000
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for August, 2000.
September 4, 2000
Fischer sales fall while profits rise
By AuntMinnie.com staff writers
August 15, 2000
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