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Ozics Group

GE Healthcare begins PMA process for 3D breast scanner | Regulatory Roundup

November 11, 2011 By MassDevice staff Leave a Comment

GE Healthcare's Senographe Essential

GE Healthcare (NYSE:GE) filed the first module of its pre-market approval application for the breast tomosynthesis option of its Senographe Essential system.

The health care giant said the first submission included a device description and non-clinical information, including "phantom testing," and detector performance evaluation. The system is intended as an add-on option for the Senographe Essential to produce 3D images for screening and diagnosis of breast cancer.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Biolase, Boston Scientific, Centers for Medicare and Medicaid Services (CMS), Cordis Corp., Cytomedix Inc., Diopsys Inc., Ethicon, Femasys Inc., Fresenius, GE Healthcare, Hologic, i-Optics, IDEV Technologies Inc., IntraPace Inc., Johnson and Johnson, Maquet Cardiovascular LLC, Nephros, Ozics Group, Regulatory Roundup, TriVascular, U-Systems, Verisante Technology

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