FDA: Page 18

GE, Volcano get 510(k) for integrated DR/US product
By AuntMinnie.com staff writers
Multimodality vendor GE Healthcare and intravascular ultrasound (IVUS) developer Volcano of Rancho Cordova, CA, said that they have received U.S. Food and Drug Administration 510(k) clearance to integrate products.
August 23, 2006
Calypso receives 510(k)
By AuntMinnie.com staff writers
Electromagnetic localization developer Calypso Medical Technologies has been granted 510(k) clearance by the U.S. Food and Drug Administration for its Calypso 4D localization system.
August 7, 2006
Fuji CR mammo approval offers new option for breast imaging
By Kate Madden Yee
Fujifilm Medical Systems USA announced today that the FDA has given final approval to its premarket approval (PMA) application for a full-field digital mammography (FFDM) system based on computed radiography (CR) technology. The approval gives breast imaging facilities a new option for going digital that should prove to be more economical than FFDM systems currently on the market, according to this Technology Review article.
July 10, 2006
2002 03 13 15 53 59 706
Planmed submits PMA for Nuance FFDM
By AuntMinnie.com staff writers
Planmed of Roselle, IL, has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for its Planmed Nuance full-field digital mammography (FFDM) system.
June 29, 2006
Medtronic to bring Endeavor to China
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has received regulatory approval from the government of the People's Republic of China for its Endeavor drug-eluting coronary stent system.
June 20, 2006
St. Jude Medical gets CE Mark
By AuntMinnie.com staff writers
Medical device manufacturer St. Jude Medical of St. Paul, MN, reported that it has received European CE Mark approval for its QuickOpt timing cycle optimization application.
June 15, 2006
FDA awards 510(k) to Barco's CardiaMetrix
By AuntMinnie.com staff writers
Image display and advanced visualization software developer Barco of Kortrijk, Belgium, has received 510(k) clearance from the U.S. Food and Drug Administration for its CardiaMetrix software.
June 13, 2006
Fuji mammo CR gets FDA nod
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received an approvable letter from the U.S. Food and Drug Administration for its computed radiography for mammography (FCRm) device.
May 30, 2006
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
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