510(k) K250587

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

K250587 is an FDA 510(k) premarket notification submitted by Ziehm-Orthoscan, Inc. for the device "Orthoscan TAU Mini C-Arm". The FDA issued a decision of Substantially Equivalent on July 2, 2025. 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.