ClearanceBrief
510(k) K251728 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic

Velacur One (LI-1100)

ApplicantSonic Incytes Medical Corp, Vancouver, CA
DecisionSubstantially Equivalent, Jun 26, 2025
ReceivedJun 5, 2025
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K251728

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.