510(k) K232552

TuxDeluxe (Size 1 6100B, Size 2 6101B) by Tuxedo Imaging, LLC — Product Code MUH

K232552 is an FDA 510(k) premarket notification submitted by Tuxedo Imaging, LLC for the device "TuxDeluxe (Size 1 6100B, Size 2 6101B)". The FDA issued a decision of Substantially Equivalent on October 20, 2023. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800.