ClearanceBrief
510(k) K162288 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

SonoSite iViz Ultrasound System

ApplicantFUJIFILM Sonosite, Inc., Bothell WA, US
DecisionSubstantially Equivalent, Sep 8, 2016
ReceivedAug 15, 2016
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K162288

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.