Siemens Medical Solutions has received an approvable letter from the Food and Drug Administration for its Mammomat Novation DR full-field digital mammography system, according to Siemens of Malvern, PA.
The device provides digital screening, diagnosis, and stereotactic biopsy capabilities, Siemens said. The Mammomat Novation DR features a 25 x 29 cm (9.8 x 11.4 inch) amorphous selenium flat-panel detector, an acquisition workstation, and a dedicated soft-copy reporting workstation, the MammoReportPlus, the firm said.
In the approvable letter for the system, the FDA indicated that the product is approvable for release to the market, pending the successful completion of an FDA inspection of Siemens' manufacturing facility in Erlangen, Germany, and completion of the device labeling for the product, the company said.
By AuntMinnie.com staff writers
July 1, 2004
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