ClearanceBrief
510(k) K260313 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic

MD-6000S Bladder Scanner

ApplicantMEDA Co., Ltd., Tianjin, CN
DecisionSubstantially Equivalent, Sep 24, 2026
ReceivedJan 30, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260313

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.