510(k) K193031

EXPD 4343P, EXPD 3643P by DRTECH Corporation — Product Code MQB

K193031 is an FDA 510(k) premarket notification submitted by DRTECH Corporation for the device "EXPD 4343P, EXPD 3643P". The FDA issued a decision of Substantially Equivalent on November 22, 2019. 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.