510(k) K253296

Digital C-ARM with 3D by Allengers Medical Systems Limited — Product Code OXO

K253296 is an FDA 510(k) premarket notification submitted by Allengers Medical Systems Limited for the device "Digital C-ARM with 3D". The FDA issued a decision of Substantially Equivalent on June 5, 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. Allengers Medical Systems Limited has at least 7 other 510(k) clearances on record.