510(k) K213438

3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory by Adaptiiv — Product Code MUJ

K213438 is an FDA 510(k) premarket notification submitted by Adaptiiv for the device "3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory". The FDA issued a decision of Substantially Equivalent on Jan 19, 2022. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050.