510(k) K241350

Clarify DL by Ge Medical Systems Israel, Functional Imaging — Product Code LLZ

K241350 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Israel, Functional Imaging for the device "Clarify DL". The FDA issued a decision of Substantially Equivalent on January 3, 2025. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Ge Medical Systems Israel, Functional Imaging has at least 3 other 510(k) clearances on record.