510(k) K231467

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF by Rayence Co., Ltd. — Product Code MQB

K231467 is an FDA 510(k) premarket notification submitted by Rayence Co., Ltd. for the device "1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF". The FDA issued a decision of Substantially Equivalent on June 21, 2023. 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. Rayence Co., Ltd. has at least 10 other 510(k) clearances on record.