An X-ray system that includes a controller to control time of x-ray exposure. These new devices now meet performance standards and consensus standards that were either not available or have been revised to meet more modern criteria since the predicate device was cleared

An X-ray system that includes a controller to control time of x-ray exposure. These new devices now meet performance standards and consensus standards that were either not available or have been revised to meet more modern criteria since the predicate device was cleared

Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news