1 Premarket Notification (510(k)), K080509, Section 20.6.8, May 5, 2008. Food and Drug Administration (FDA) Center for Devices and Radiological Health.
2 Premarket Notification (510(k)), K070288, June 18, 2007. Food and Drug Administration (FDA) Center for Devices and Radiological Health.
3 Premarket Notification (510(k)), K040812, Sept. 2, 2004. Food and Drug Administration (FDA) Center for Devices and Radiological Health.
