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Is infrared FDA approved for this purpose? Is the ThermoBreastScan system approved too?

April 26, 2017Approved fda infrared purpose system ThermoBreastScan

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Is infrared FDA approved for this purpose? Is the ThermoBreastScan system approved too?

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The efficacy of infrared imaging for adjunctive breast cancer screening was demonstrated to the FDAs satisfaction in 1982. Since then, all systems that are used for this purpose are given an FDA 510k clearance, under CFR 21 884.2980.