The @US_FDA has issued a final order to reclassify certain radiological medical image analyzers, including CADe devices, from Class III devices to Class II devices. Find out more about the Final Order https://go.usa.gov/xdrts  

The @US_FDA has issued a final order to reclassify certain radiological medical image analyzers, including CADe devices, from Class III devices to Class II devices. Find out more about the Final Order https://go.usa.gov/xdrts 

Source: Food and Drug Adminstration (FDA): CDRHNew - January 22, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news