510(k) K242822

ART-Plan+ (v.3.0.0) by Therapanacea Sas — Product Code MUJ

K242822 is an FDA 510(k) premarket notification submitted by Therapanacea Sas for the device "ART-Plan+ (v.3.0.0)". The FDA issued a decision of Substantially Equivalent on February 25, 2025. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Therapanacea Sas has at least 6 other 510(k) clearances on record.