510(k) K242778

X Sensor (Model: IOS-A15IF, HDI-15DGF) by Qpix Solutions, Inc. — Product Code MUH

K242778 is an FDA 510(k) premarket notification submitted by Qpix Solutions, Inc. for the device "X Sensor (Model: IOS-A15IF, HDI-15DGF)". The FDA issued a decision of Substantially Equivalent on October 11, 2024. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Qpix Solutions, Inc. has at least 2 other 510(k) clearances on record.