FDA: Page 19

AMS gets Catella 510(k)
By AuntMinnie.com staff writers
American Medical Sales has received Food and Drug Administration 510(k) marketing clearance for its new PACS workstation software, Catella Version 4.0.
November 22, 2005
Toshiba notches 510(k) for Infinix VC-i
By AuntMinnie.com staff writers
Toshiba America Medical Systems has received Food and Drug Administration 510(k) marketing clearance for its Infinix VC-i system with a large field-of-view 12 x 16-inch flat-panel detector.
November 21, 2005
Planmed
By Kate Madden Yee
At the RSNA show, Planmed of Roselle, IL, will highlight two mammography systems: Planmed Nuance Classic and the work-in-progress Nuance, a full-field digital mammography unit.
November 6, 2005
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Fujifilm Medical Systems USA
By Kate Madden Yee
Stamford, CT-based Fujifilm Medical Systems USA will highlight multiple versions of its Fuji CR for Mammography (FCRm) technology, as well as its Multi-Modality Breast Imaging Workstation.
November 6, 2005
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DOBI Medical International
By Kate Madden Yee
Optical breast imaging technology developer DOBI Medical International of Mahwah, NJ, will display its Dynamic Optical Breast Imaging (DOBI) ComfortScan system.
November 6, 2005
DOBI signs Beardsworth for PMA trial
By AuntMinnie.com staff writers
DOBI Medical International has hired Beardsworth Consulting Group of Flemington, NJ, to manage the clinical trial of its ComfortScan optical imaging system.
November 2, 2005
MeVis gets 510(k)
By AuntMinnie.com staff writers
The MeVis Center for Medical Diagnostic Systems and Visualization in Bremen, Germany, has received U.S. Food and Drug Administration 510(k) marketing clearance for its software products, MeVis LiverAnalyzer and MeVis LiverViewer.
October 31, 2005
Double Black, WIDE get 510(k) for mammo LCD
By AuntMinnie.com staff writers
Monitor distributor Double Black Imaging said that its partner WIDE has received Food and Drug Administration 510(k) clearance for its IF2105M LCD system, opening the door for its use in digital mammography applications.
October 20, 2005
Medtronic submits PMA module for Endeavor
By AuntMinnie.com staff writers
Medical device developer Medtronic has submitted the first premarket approval application (PMA) module for its Endeavor drug-eluting coronary stent to the Food and Drug Administration.
October 9, 2005
AnthroCare gets 510(k) for bone cement
By AuntMinnie.com staff writers
Medical device developer AnthroCare of Austin, TX, has received 510(k) clearance from the Food and Drug Administration for a new bone cement designed to be used during vertebroplasty or kyphoplasty procedures.
October 9, 2005
SoftScan trial under way
By AuntMinnie.com staff writers
Optical molecular imaging developer ART Advanced Research Technologies said that a clinical study of its SoftScan breast imaging system has begun at Massachusetts General Hospital in Boston.
October 6, 2005
IDSI notches Italian order
By AuntMinnie.com staff writers
CT laser mammography (CTLM) developer Imaging Diagnostic Systems (IDSI) has sold its third CTLM system in Italy.
September 29, 2005
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