FDA: Page 23

Shared PET gets 510(k)
By AuntMinnie.com staff writers
PET services provider Shared PET Imaging has received Food and Drug Administration 510(k) marketing clearance for its ClarityPET software, according to the Canton, OH-based firm.
July 28, 2004
Final 510(k) decisions for June 2004
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for June 2004:
July 6, 2004
Planar gets 510(k) for flat-panel mammo display
By AuntMinnie.com staff writers
Monitor manufacturer Planar Systems has received 510(k) clearance from the Food and Drug Administration for a 5-megapixel flat-panel display designed for use with full-field digital mammography (FFDM) systems.
June 22, 2004
Final 510(k) decisions for May 2004
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for May 2004:
June 7, 2004
U.S. Electronics gets 510(k)
By AuntMinnie.com staff writers
Display distributor U.S. Electronics has received Food and Drug Administration 510(k) marketing clearance for Totuku's ME511L five-megapixel monochrome LCD.
June 2, 2004
Cedara gets 510(k) for I-ReadMammo
By AuntMinnie.com staff writers
Cedara Software has received Food and Drug Administration 510(k) marketing clearance for I-ReadMammo, a new mammography reading workstation for diagnosis and screening.
May 18, 2004
Prowess gets 510(k) clearance
By AuntMinnie.com staff writers
Radiation treatment-planning software developer Prowess of Chico, CA, has received 510(k) clearance from the Food and Drug Administration for its Prowess Panther direct-aperture optimization-based intensity-modulated radiation therapy (IMRT) planning system.
May 10, 2004
Varian receives 510(k) for brachytherapy afterloader
By AuntMinnie.com staff writers
Radiation oncology firm Varian Medical Systems of Palo Alto, CA, has received 510(k) marketing clearance from the Food and Drug Administration for a new single-channel device for delivering high-dose-rate (HDR) brachytherapy.
April 26, 2004
Nucletron gets 510(k) for Simulix Evolution
By AuntMinnie.com staff writers
Radiotherapy provider Nucletron has received Food and Drug Administration 510(k) marketing clearance for its Simulix Evolution digital simulator.
February 9, 2004
Sectra breast workstation receives 510(k)
By AuntMinnie.com staff writers
Swedish PACS and digital mammography developer Sectra has received U.S. Food and Drug Administration 510(k) marketing clearance for its IDS5 dedicated breast imaging workstation.
January 28, 2004
Varian gets 510(k) for 3-D
By AuntMinnie.com staff writers
Varian Medical Systems has received U.S. Food and Drug Administration 510(k) marketing clearance for its 3-D cone-beam CT imaging system on a radiation therapy simulation and verification device.
January 7, 2004
Swissray International
By Robert Bruce
Direct digital developer Swissray is introducing ddRRealtime, a 15-image-per-second, high-resolution hardware retrofit to existing Swissray ddR systems.
November 17, 2003
Previous Page
Page 23 of 32
Next Page