Introduction

One of the most recent advances in mammography is digital mammography. When first approved by the US Food and Drug Administration (FDA) in 2000, digital mammography systems were categorized as class III devices, because they were then considered novel systems for screening and diagnosing breast cancer [1]. The class III device category usually includes new technologies that have not been widely used and require proof of safety and effectiveness before the product can be approved for marketing. Other examples of class III devices include heart valves and orthopedic implants. As of January 2012, 22 digital mammography systems have been approved by the FDA (Table 2.1). From the time the first digital mammography system, the GE Senographe 2000D, was approved in 2000 until today, digital mammography has been validated by multiple scientific studies [2–4]. The benefits and risks of digital versus film-screen mammography have been well documented and well described. In November 2010 the FDA reclassified digital mammography systems as class II devices. Class I and class II devices pose lower risks and include adhesive bandages, wheelchairs, and many medical imaging technologies, such as magnetic resonance imaging (MRI) scanners and film-screen mammography. The class II device category usually requires submission of a premarket notification or a 510(k) to establish that the product is substantially equivalent to a device already on the market [1].