ClearanceBrief
510(k) K230727 ยท IZI System, X-Ray, Angiographic

SPY Portable Handheld Imaging (SPY-PHI) System

ApplicantNovadaq Technologies Ulc (A Part of Stryker), Burnaby, CA
DecisionSubstantially Equivalent, Jun 5, 2023
ReceivedMar 16, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K230727

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.