510(k) K210988

Yushan X-Ray Flat Panel Detector with DROC by Innocare Optoelectronics Corp. — Product Code MQB

K210988 is an FDA 510(k) premarket notification submitted by Innocare Optoelectronics Corp. for the device "Yushan X-Ray Flat Panel Detector with DROC". The FDA issued a decision of Substantially Equivalent on April 21, 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. Innocare Optoelectronics Corp. has at least 5 other 510(k) clearances on record.