FDA: Page 19

FDA issues warning to Guidant
By AuntMinnie.com staff writers
Interventional device developer Guidant of Indianapolis said it has received a warning letter from the FDA related to its inspection and Form 483 observations of the firm's cardiac rhythm management facility in St. Paul, MN, conducted in September this year.
December 26, 2005
Clario gets 510(k)
By AuntMinnie.com staff writers
Imaging processing developer Clario Medical Imaging has received 510(k) marketing clearance from the U.S. Food and Drug Administration for its z3D Contrast Acuity software.
December 13, 2005
New 510(k) for Varian
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received FDA 510(k) clearance for a new proton therapy eye dose calculation module that has been incorporated into company's Eclipse radiation therapy treatment planning system.
December 6, 2005
Vascular Solutions receives Twin-Pass 510(k)
By AuntMinnie.com staff writers
Interventional technology developer Vascular Solutions of Minneapolis has received U.S. Food and Drug Administration 510(k) clearance for its Twin-Pass dual-access catheter, the firm reported.
December 1, 2005
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
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