ClearanceBrief
510(k) K201296 ยท LLZ System, Image Processing, Radiological

i-Rapha Solution

ApplicantIrm, Inc., Gangnam-Gu, KR
DecisionSubstantially Equivalent, Jul 9, 2020
ReceivedMay 15, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K201296

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.