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FDA completes review of digital mammography system.
2004 AUG 5 - (NewsRx.com & NewsRx.net) -- Siemens Medical Solutions has received an approvable letter from the U.S. Food & Drug Administration (FDA) for the MAMMOMAT NovationDR, a full-field digital mammography system. This letter indicates that the FDA has completed its scientific review of the company's pre-market approval (PMA) application.
In the approvable letter for this device, the FDA indicates that the MAMMOMAT NovationDR 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 system.
The new system provides digital screening, diagnosis, and stereotactic biopsy capabilities in one system. Its flat panel detector enables a direct ...
- FDA approves PMA for MAMMOMAT NovationDR.
- Magazine article from: Women's Health Weekly September 23, 2004 700+ words
...system. "The MAMMOMAT NovationDR offers a comprehensive...mammography." The new MAMMOMAT NovationDR features a flat...detector size of the MAMMOMAT NovationDR also enables imaging...prepared by Women's Health Weekly editors from staff...
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- Siemens Installs First Prototype Flat Detector Full-Field Digital Mammography...
- Press release article from: PR Newswire January 14, 2003 700+ words
...new system, which is called the MAMMOMAT NovationDR* in Europe and other countries...patient management and care. "With MAMMOMAT NovationDR, Siemens intends to keep all the...is being performed with the new MAMMOMAT NovationDR that will compare the diagnostic...
- Product Briefs.
- Newspaper article from: Diagnostics & Imaging Week July 8, 2004 700+ words
...approvable letter from the FDA for the Mammomat NovationDR, a full-field digital mammography...indicated in the letter that the Mammomat NovationDR is approvable for release to the...the labeling for the system. The Mammomat NovationDR provides digital screening, diagnosis...
- Siemens Receives FDA Approvable Letter for Its Digital Mammography Solution.
- Press release article from: PR Newswire July 1, 2004 700+ words
...device, the FDA indicates that the MAMMOMAT NovationDR is approvable for release to the...Division. "Once approved, the MAMMOMAT NovationDR will offer our customers a comprehensive...for modern mammography." The new MAMMOMAT NovationDR provides digital screening, diagnosis...