510(k) K201528

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

K201528 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 October 11, 2020. 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.