510(k) K241765

PLANET Onco Dose (3.2) by Dosisoft SA — Product Code LLZ

K241765 is an FDA 510(k) premarket notification submitted by Dosisoft SA for the device "PLANET Onco Dose (3.2)". The FDA issued a decision of Substantially Equivalent on March 14, 2025. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Dosisoft SA has at least 7 other 510(k) clearances on record.