510(k) K190978

RefleXion Medical Radiotherapy System by Reflexion Medical, Inc. — Product Code IYE

K190978 is an FDA 510(k) premarket notification submitted by Reflexion Medical, Inc. for the device "RefleXion Medical Radiotherapy System". The FDA issued a decision of Substantially Equivalent on March 12, 2020. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Reflexion Medical, Inc. has at least 2 other 510(k) clearances on record.