ClearanceBrief
510(k) K223564 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

X-CUBE 50, X-CUBE 60

ApplicantAlpinion Medical Systems Co., Ltd., Seoul, KR
DecisionSubstantially Equivalent, Apr 17, 2023
ReceivedNov 29, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K223564

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.