Regulatory: Page 231

Medicsight launches ColonCAR software
By AuntMinnie.com staff writers
Computer-aided detection firm Medicsight has released its image analysis software tool for virtual colonoscopy, ColonCAR (Computer-Assisted Reader) 1.2.1.
November 26, 2006
Spectrum Dynamics receives 510(k) for D-SPECT
By AuntMinnie.com staff writers
Israeli gamma camera developer Spectrum Dynamics of Tirat Hacarmel has received clearance from the U.S. Food and Drug Administration for its D-SPECT cardiac system with BroadView imaging technology.
November 26, 2006
Alara gets FDA clearance for CRystalView R200
By AuntMinnie.com staff writers
Computed radiography (CR) developer Alara has received U.S. Food and Drug Administration clearance for its CRystalView R200 desktop CR system for general radiography applications.
November 26, 2006
Amicas nets 510(k) for Vision Series 5
By AuntMinnie.com staff writers
PACS vendor Amicas reported that it has received U.S. Food and Drug Administration clearance to perform primary interpretation of digital mammography on its Vision Series PACS, version 5.0.
November 21, 2006
IMCO submits IMCO-Stat to FDA
By AuntMinnie.com staff writers
PACS vendor IMCO Technologies of Pewaukee, WI, has submitted its IMCO-Stat communications technology software to the U.S. Food and Drug Administration for review and clearance.
November 19, 2006
Mercury gets FDA OK
By AuntMinnie.com staff writers
Mercury Computer Systems said that the U.S. Food and Drug Administration granted the company clearance to market its Visage products.
November 16, 2006
eRad nets 510(k) for mammography viewing
By AuntMinnie.com staff writers
PACS firm eRad reported that it has received U.S. Food and Drug Administration 510(k) clearance for soft-copy viewing of digital mammography images.
November 16, 2006
EDDA gets 510(k) for liver software
By AuntMinnie.com staff writers
Computer-aided detection software developer EDDA Technology of Princeton Junction, NJ, has received clearance from the U.S. Food and Drug Administration to market its IQQA-Liver application.
November 15, 2006
FDA approves ACR to accredit Fuji CR mammo
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has approved the American College of Radiology to accredit the FCRm computed radiography mammography system from Fujifilm Medical Systems USA.
November 14, 2006
Viasys receives 510(k)
By AuntMinnie.com staff writers
Medical technology developer Viasys Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its Sonora and Sonora/tek digital transcranial Doppler ultrasound systems.
November 14, 2006
NAS receives 510(k) for ClearPath
By AuntMinnie.com staff writers
Radiation therapy products developer North American Scientific (NAS) said it has received 510(k) clearance from the U.S Food and Drug Administration to market the high-dose-rate radiation treatment design of ClearPath, a multicatheter breast brachytherapy device.
November 13, 2006
Boston Scientific, GE integrate informatics apps
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific said that the U.S. Food and Drug Administration approved the Natick, MA-based firm's Latitude 2.0 patient monitoring software with remote data integration capabilities.
November 8, 2006
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