510(k) K221190

ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System by Siemens Medical Solutions USA, Inc. — Product Code IYN

K221190 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on Aug 16, 2022. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Siemens Medical Solutions USA, Inc. has 783 other 510(k) clearances on record.