Regulatory: Page 283

Final 510(k) approvals for June 2002
Issued July 7, 2002
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 2002.
July 6, 2002
PointDX gets clearance for REX workstation
By AuntMinnie.com staff writers
PointDX received Food and Drug Administration 510(k) clearance in June for its integrated image analysis and structured reporting REX workstation.
July 4, 2002
Ultrasonix gets FDA clearance for ultrasound system
By AuntMinnie.com staff writers
The Food and Drug Administration has given 510(K) clearance to the Ultrasonix 500 ultrasound imaging scanner, developed by Ultrasonix of Vancouver, British Columbia.
June 25, 2002
TomTec receives clearance for three ultrasound products
By AuntMinnie.com staff writers
TomTec Imaging Systems received 510(k) clearance to market its new Cardio-Scan cardiac ultrasound image acquisition product.
June 25, 2002
GE gets FDA clearance for dual-slice CT
By AuntMinnie.com staff writers
The Food and Drug Administration has cleared GE Medical Systems’ HiSpeed Dual, a dual-slice entry-level system.
June 23, 2002
NAS pulls Apomate filing
By AuntMinnie.com staff writers
North American Scientific has temporarily withdrawn its Apomate radiopharmaceutical investigational new drug (IND) application from the Food and Drug Administration.
June 17, 2002
AMR gets FDA OK for FilmSaver
By AuntMinnie.com staff writers
American Medical Resources has received Food and Drug Administration clearance to market its FilmSaver software.
June 16, 2002
Varian gets clearance for new Helios software
By AuntMinnie.com staff writers
Varian Medical Systems has received Food and Drug Administration 510(k) clearance for a new version of its Helios intensity modulated radiation therapy (IMRT) treatment planning software.
June 16, 2002
Fonar gets CE Mark for Stand-Up MRI
By AuntMinnie.com staff writers
MRI vendor Fonar has received the European CE Mark for its Stand-Up MRI scanner.
June 9, 2002
Final PMA approvals for May 2002
Issued June 7, 2002
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of premarket approvals (PMA), product development protocols (PDP), supplement and notice decisions from the previous month. The following decisions were rendered for May 2002.
June 9, 2002
Final 510(k) approvals for May 2002
Issued June 5, 2002
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 2002.
June 6, 2002
Pennsylvania takes hard line on self-referral CT screening
By AuntMinnie.com staff writers
Pennsylvania Physician General Dr. Robert Muscalus and Department of Environmental Protection Secretary David Hess have issued a public advisory against self-referral CT screening exams conducted without the advice of a physician.
May 30, 2002
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