510(k) K243443

EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP by DRTECH Corporation — Product Code MQB

K243443 is an FDA 510(k) premarket notification submitted by DRTECH Corporation for the device "EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP". The FDA issued a decision of Substantially Equivalent on March 19, 2025. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. DRTECH Corporation has at least 10 other 510(k) clearances on record.