510(k) K251363

ProKnow DS by Elekta Solutions AB — Product Code LLZ

K251363 is an FDA 510(k) premarket notification submitted by Elekta Solutions AB for the device "ProKnow DS". The FDA issued a decision of Substantially Equivalent on October 8, 2025. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Elekta Solutions AB has at least 10 other 510(k) clearances on record.