Imaging Diagnostic gets Class III classification for breast imaging tool

08/10/2011 | HealthImaging.com

Imaging Diagnostic Systems will have to file a premarket approval application with the FDA after the agency classified its CTLM system, a breast imaging device, as a Class III device. The agency concluded that the company's device "is not substantially equivalent" to devices cleared through the 510(k) process or to systems categorized as Class I or Class II devices.

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