Results were compiled from the manufacturer-held clinical validation data presented in Section {MQ}5.4.1.2 above{MQ}.Section {MQ}5.3{MQ}, Clinical Data from Published Literature, and Section {MQ}5.4.1{MQ}, Manufacturer-Held Clinical Data:Published clinical data of the EPIQ System from peer-reviewed journal articles have demonstrated that the device has been used for most clinical applications in up to 169,509 patients as intended.Manufacturer-held clinical validation data also display 2,482 clinical exams have been conducted with the EPIQ System.