There is no published clinical evidence describing the use of the EPIQ System with L15-7io for intraoperative ultrasound imaging examinations.However, appropriate biological safety testing has been conducted for this transducer based on its patient contact type and duration to substantiate its safety in clinical use.Also, see Section {MQ}5.4.1.2 below{MQ} for the manufacturer-held simulated clinical validation data to support this safety claim.