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Imaging Diagnostic Seeks FDA Clearance For Mammography Adjunct.(Brief Article)
2001 OCT 18 - (NewsRx.com & NewsRx.net) -- Imaging Diagnostic Systems has received CE Marking, UL listing, and recently ISO 9002 certification permitting the company to market its product internationally. The company is seeking Premarket Approval (PMA) from the Food and Drug Administration (FDA) for its CTLM system to be used as an adjunct to mammography to aid in the detection of breast abnormalities.
Under the new modular submission approach, the company's PMA application has been divided into different modules, each of which will contain documentation required for the FDA review. The company has now submitted ...
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Source: HighBeam Research, Imaging Diagnostic Seeks FDA Clearance For Mammography Adjunct.(Brief...