ClearanceBrief
510(k) K260519 ยท MOS Coil, Magnetic Resonance, Specialty

Smart Fit TorsoCardiac 1.5T

ApplicantPhilips Healthcare (Suzhou) Co., Ltd., Suzhou, CN
DecisionSubstantially Equivalent, Mar 20, 2026
ReceivedFeb 17, 2026
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K260519

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.