ClearanceBrief
510(k) K163505 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

ARIETTA PRECISION

ApplicantHitachi , Ltd., Wallingford CT, US
DecisionSubstantially Equivalent, May 30, 2017
ReceivedDec 14, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K163505

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.