510(k) K211511

decimal Bolus by .Decimal, LLC — Product Code MUJ

K211511 is an FDA 510(k) premarket notification submitted by .Decimal, LLC for the device "decimal Bolus". The FDA issued a decision of Substantially Equivalent on July 1, 2021. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. .Decimal, LLC has at least 10 other 510(k) clearances on record.