FDA: Page 27

Lodox gets 510(k) for CCD full-body x-ray

By AuntMinnie.com staff writers

X-ray developer Lodox Systems has received U.S. Food and Drug Administration 510(k) clearance to market its charge-coupled device (CCD) full-body x-ray system.

August 7, 2002

Avia multimodality workstation gains 510(k) clearance

By AuntMinnie.com staff writers

Hitachi Medical Systems America has received U.S. Food and Drug Administration 510(k) clearance to market the Avia multimodality workstation.

July 23, 2002

Final PMA approvals for June 2002

Issued July 12, 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 June 2002.

July 11, 2002

Hologic gets approvable letter for Selenia FFDM system

By AuntMinnie.com staff writers

Hologic has received an approvable letter from the FDA for Lorad Selenia.

July 10, 2002

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

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

Final PMA approvals for April 2002

Updated May 9, 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 April 2002:

May 9, 2002

Final 510(k) approvals for April 2002

Issued May 6, 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 April 2002.

May 5, 2002

Final 510(k) approvals for March 2002

Issued April 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 March 2002.

April 4, 2002

Hologic gets clearance for FFDM system

By AuntMinnie.com staff writers

Mammography and digital x-ray developer Hologic has received Food and Drug Administration approval of a premarket approval (PMA) application for its Lorad digital breast imaging system.

March 18, 2002

Final 510(k) approvals for February 2002

Issued March 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 February 2002.

March 4, 2002

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