FDA Proposed Reclassification of MIMS

FDA Issued a Proposed Order to Down-Classify Certain Radiological Medical Image Analyzers, which include computer-assisted detection devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices, from class III to class II devices.  If finalized, this proposed order will reclassify computer-assisted detection devices for certain radiological applications from Class III devices requiring premarket approval, to Class II devices, requiring a less burdensome premarket notification (510(k)) with special controls.

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