Display Devices for Diagnostic Radiology; Guidance for Industry and Food and Drug Administration Staff; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Display Devices for Diagnostic Radiology." This guidance document provides recommendations for the types of information you should provide in your premarket notification submission (510(k)) for display devices intended for diagnostic radiology with the assigned product code PGY. This guidance replaces a previously issued final guidance entitled "Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions" issued on May 30, 2008.