510(k) K263150

V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. — Product Code IYN

K263150 is an FDA 510(k) premarket notification submitted by Samsung Medison Co., Ltd. for the device "V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on Oct 8, 2026. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Samsung Medison Co., Ltd. has 74 other 510(k) clearances on record.