ClearanceBrief
510(k) K181460 ยท LLZ System, Image Processing, Radiological

OnePacs System

ApplicantOnepacs, LLC, Palo Alto CA, US
DecisionSubstantially Equivalent, Oct 11, 2018
ReceivedJun 4, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K181460

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.