ClearanceBrief
510(k) K251370 ยท KPS System, Tomography, Computed, Emission

Cartesion Prime (PCD-1000A/3) V10.21

ApplicantCanon Medical Systems Corporation, Otawara-Shi, JP
DecisionSubstantially Equivalent, Dec 1, 2025
ReceivedMay 2, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251370

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.