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Hologic, Inc. ©2023 All rights reserved. Indications for Use: The SuperSonic Imagine - SuperSonic® 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 SuperSonic 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. In addition, the SuperSonic Imagine - SuperSonic MACH ultrasound diagnostic systems and associated transducers are intended for: measurements of abdominal anatomical structures; measurements of broadband shear wave speed, and tissue stiffness in internal structures of the liver and the spleen; measurements of brightness ratio between liver and kidney; visualization of abdominal vascularization, microvascularization and perfusion; quantification of abdominal vascularization and perfusion. The ShearWave speed, beam attenuation, viscosity and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion, the quantification of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease. 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. 2021 Hologic Inc., All rights reserved. Hologic, Aixplorer, ShearWave, SonicPad™, SuperSonic, SuperSonic MACH and associated logos are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and other countries. This information is intended for medical professionals in the U.S. and other markets and is not intended as a product solicitation or promotion where such activities are prohibited. Because Hologic materials are distributed through websites, eBroadcasts and tradeshows, it is not always possible to control where such materials appear. For specific information on what products are available for sale in a particular country, please contact your local Hologic representative.