510(k) K260227

EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H by DRTECH Corporation — Product Code KPR

K260227 is an FDA 510(k) premarket notification submitted by DRTECH Corporation for the device "EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H". The FDA issued a decision of Substantially Equivalent on September 8, 2026. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. DRTECH Corporation has at least 10 other 510(k) clearances on record.