References:
1. Indications for Use: The SuperSonic Mach 30, previously known as the Aixplorer MACH, range ultrasound diagnostic systems and transducers, are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging and Doppler fluid flow analysis of the human body. The Aixplorer MACH® ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Transrectal, Transvaginal, Urology, Neonatal/Adult Cephalic and Non-invasive Cardiac. It is intended for use by licensed personnel qualified to direct the use of the medical ultrasound devices. CE certificate no. 26415, FDA cleared K180572.