Regulatory: Page 298

Imaging Diagnostic gets CE Mark
By AuntMinnie.com staff writers
Laser breast imaging developer Imaging Diagnostic Systems said it has received regulatory approval to apply the CE Mark to its Computed Tomography Laser Mammography System.
January 17, 2001
Final PMA approvals for December 2000
Issued January 12, 2001
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 December 2000.
January 11, 2001
Imaging Diagnostic sells three CTLM units
By AuntMinnie.com staff writers
January 11, 2001
Final 510(k) approvals for December 2000
Issued January 5, 2001
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 December 2000.
January 4, 2001
Ultrasound ergonomics firm looks at workplace risks
By AuntMinnie.com staff writers
January 1, 2001
ARRT to adopt MQSA mammography standards
By AuntMinnie.com staff writers
December 26, 2000
FDA Guidance on submitting a 510(k) for wireless telemetry medical devices
Issued December 12, 2000
This document provides direction to manufacturers on deciding when to submit a 510(k) for a change to their existing wireless telemetry medical device or to a medical device incorporating wireless telemetry as a feature.
December 11, 2000
Final PMA approvals for November 2000
Issued December 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 November 2000.
December 11, 2000
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
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