510(k) K161942

PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector by Perkinelmer, Inc. — Product Code MQB

K161942 is an FDA 510(k) premarket notification submitted by Perkinelmer, Inc. for the device "PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector". The FDA issued a decision of Substantially Equivalent on September 1, 2016. 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. Perkinelmer, Inc. has at least 10 other 510(k) clearances on record.