510(k) K230811

Digital Intraoral X-Ray Sensor by Iray Imaging Technology (Haining) Limited — Product Code MUH

K230811 is an FDA 510(k) premarket notification submitted by Iray Imaging Technology (Haining) Limited for the device "Digital Intraoral X-Ray Sensor". The FDA issued a decision of Substantially Equivalent on April 21, 2023. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Iray Imaging Technology (Haining) Limited has at least 3 other 510(k) clearances on record.