510(k) K213497

ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) by H&abyz Co., Ltd. — Product Code MQB

K213497 is an FDA 510(k) premarket notification submitted by H&abyz Co., Ltd. for the device "ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)". The FDA issued a decision of Substantially Equivalent on November 15, 2021. 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. H&abyz Co., Ltd. has at least 3 other 510(k) clearances on record.