FDA: Page 18

Novadaq lands Spy revision 510(k)
By AuntMinnie.com staff writers
Novadaq Technologies of Toronto said it has received 510(k) clearance from the U.S. Food and Drug Administration for a labeling revision of its Spy intraoperative imaging system.
May 8, 2006
Barco gets FDA 510(k) for Voxar 3D Enterprise
By AuntMinnie.com staff writers
AUSTIN, TX - Image display and advanced visualization software developer Barco has received 510(k) clearance from the U.S. Food and Drug Administration for Voxar 3D Enterprise, the client-server version of its flagship 3D technology.
April 27, 2006
NAS gets FDA 510(k) for low-dose breast brachytherapy
By AuntMinnie.com staff writers
Radiation therapy firm North American Scientific (NAS) has received 510(k) clearance from the U.S. Food and Drug Administration to market a low-dose-rate radiation treatment version of its breast brachytherapy product.
April 25, 2006
Siemens gets FDA nod for Mammomat mobile
By AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions reported that the U.S. Food and Drug Administration has issued a premarket approval (PMA) supplement to allow marketing of the company's Mammomat Novation full-field digital mammography (FFDM) system for mobile use.
April 24, 2006
Maxant gets 510(k) for MediPort
By AuntMinnie.com staff writers
X-ray illuminator firm Maxant Technologies of Niles, IL, has received U.S. Food and Drug Administration 510(k) clearance for its MediPort line of digital workstations.
April 6, 2006
Siemens gets 510(k) for MVision
By AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions has received 510(k) clearance from the U.S. Food and Drug Administration for its MVision Megavoltage Cone Beam imaging package for radiation therapy applications.
April 3, 2006
GE receives Innova 510(k) clearance
By AuntMinnie.com staff writers
GE Healthcare said that the U.S. Food and Drug Administration has provided 510(k) clearance for its Innova 3131(IQ) and 2121(IQ) digital flat-panel biplane imaging systems.
March 13, 2006
Boston Scientific submits final Liberté PMA module
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has submitted the final module of a premarket approval (PMA) application to the Food and Drug Administration (FDA) for its Taxus Liberté paclitaxel-eluting coronary sent system.
March 8, 2006
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
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