ClearanceBrief
510(k) K260321 ยท LLZ System, Image Processing, Radiological

HipGuide (V 1.0.0.0)

ApplicantOrthopedic Driven Imaging, LLC, Gainesville FL, US
DecisionSubstantially Equivalent, May 8, 2026
ReceivedJan 30, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260321

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.