510(k) K252579

Orthoscan TAU MVP Mini C-Arm System by Ziehm-Orthoscan, Inc. — Product Code OXO

K252579 is an FDA 510(k) premarket notification submitted by Ziehm-Orthoscan, Inc. for the device "Orthoscan TAU MVP Mini C-Arm System". The FDA issued a decision of Substantially Equivalent on January 14, 2026. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Ziehm-Orthoscan, Inc. has at least 2 other 510(k) clearances on record.