FDA: Page 22

Neurognostics nets 510(k)

By AuntMinnie.com staff writers

Functional MRI (fMRI) applications developer Neurognostics has received 510(k) market clearance from the U.S. Food and Drug Administration for its MindState functional data acquisition device (fDAD).

February 1, 2005

Implant Sciences gets 510(k) for ytterbium-169

By AuntMinnie.com staff writers

Radiation oncology and interventional cardiology firm Implant Sciences said it has received clearance of its 510(k) application from the U.S. Food and Drug Administration.

January 26, 2005

IDSI alters course on FDA PMA

By AuntMinnie.com staff writers

CT laser mammography (CTLM) developer Imaging Diagnostic Systems (IDSI) in a letter to shareholders today said that it is altering its course for obtaining U.S. Food and Drug Administration premarket approval (PMA) for its CTLM device.

January 26, 2005

CTI gets 510(k) for neuro tool

By AuntMinnie.com staff writers

PET developer CTI Molecular Imaging said that its subsidiary, CTI Mirada Solutions, has received U.S. Food and Drug Administration 510(k) clearance to market Scenium, a quantification application for the analysis of neurological PET scans.

January 17, 2005

Resonant gets 510(k)

By AuntMinnie.com staff writers

Radiotherapy device manufacturer Resonant Medical said that its Restitu 3D ultrasound image-guided radiation therapy platform has received 510(k) marketing clearance from the Food and Drug Administration.

December 20, 2004

Analogic gets 510(k) for new flat-panel detector

By AuntMinnie.com staff writers

Analogic has received 510(k) clearance from the Food and Drug Administration for the GR17 flat-panel digital detector developed by Analogic subsidiary Anrad.

November 1, 2004

ev3 stent gets 510(k)

By AuntMinnie.com staff writers

Interventional device firm ev3 of Plymouth, MN, has received Food and Drug Administration 510(k) marketing clearance for its Protégé GPS nitinol self-expanding long stent.

October 20, 2004

Final 510(k) decisions for September 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 September 2004:

October 5, 2004

Final 510(k) decisions for August 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 August 2004:

September 6, 2004

FDA approves Siemens FFDM system

By AuntMinnie.com staff writers

Multimodality vendor Siemens Medical Solutions has received FDA premarket approval for its Mammomat Novation DR full-field digital mammography system.

August 22, 2004

Final PMA decisions for July 2004

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 July 2004.

August 11, 2004

Final 510(k) decisions for July 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 July 2004:

August 9, 2004

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