FDA: Page 26

Final PMA Approvals for November 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 November 2002.

December 4, 2002

Quantum gets C-arm 510(k) clearance

By AuntMinnie.com staff writers

Radiography developer Quantum Medical Imaging has received Food and Drug Administration 510(k) clearance for an integrated C-arm called the QV-800 Universal System. The product is designed as a single-panel digital receptor for use within a hospital’s trauma unit.

November 26, 2002

Analogic, IMS form FFDM alliance

By AuntMinnie.com staff writers

Peabody, MA-based imaging equipment vendor Analogic has joined forces with Internazionale Medico Scientifica (IMS) of Bologna, Italy in a five-year strategic alliance for the exchange of mammography product and technology information.

November 26, 2002

Nucletron product gets FDA 510(k) clearance

By AuntMinnie.com staff writers

Dutch radiation therapy firm Nucletron has gained U.S. Food and Drug Administration 510(k) clearance for its Spot Pro 3-D ultrasound planning system for all seed-implant techniques.

November 19, 2002

Final 510(k) decisions for November 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 November 2002.

November 5, 2002

Final 510(k) decisions for October 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 October 2002.

October 3, 2002

Instrumentarium gets 510(k) clearance for digital mammo systems

By AuntMinnie.com staff writers

Mammography and x-ray firm Instrumentarium Imaging has received U.S. Food and Drug Administration 510(k) clearance to market its Delta 32 and Delta 32 TACT diagnostic digital breast imaging systems.

October 2, 2002

Final 510(k) decisions for August 2002

Updated September 23, 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 August 2002.

September 22, 2002

FDA Radiological Devices panel to discuss breast thermal imaging

Issued September 20, 2002
An October 16, 2002 meeting of the FDA Radiological Devices Panel of the Medical Devices Advisory Committee will discuss, make recommendations, and vote on a premarket approval application for a device that produces a computerized thermal image of the breast of women recommended for biopsy.

September 20, 2002

IDSI installs CTLM in Berlin

By AuntMinnie.com staff writers

Laser breast imaging firm Imaging Diagnostic Systems has installed its CT Laser Mammography (CTLM) system at the Humboldt University of Berlin, Charité Hospital.

September 11, 2002

Final PMA approvals for August 2002

Issued September 10, 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 August 2002.

September 9, 2002

Final 510(k) decisions for September 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 September 2002.

September 5, 2002

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