510(k) K170946

Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant by Skanray Technologies Private Limited — Product Code OXO

K170946 is an FDA 510(k) premarket notification submitted by Skanray Technologies Private Limited for the device "Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant". The FDA issued a decision of Substantially Equivalent on November 24, 2017. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Skanray Technologies Private Limited has at least 3 other 510(k) clearances on record.