510(k) K240290

AiMIFY (1.x) by Subtle Medical, Inc. — Product Code LLZ

K240290 is an FDA 510(k) premarket notification submitted by Subtle Medical, Inc. for the device "AiMIFY (1.x)". The FDA issued a decision of Substantially Equivalent on Aug 21, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Subtle Medical, Inc. has at least 10 other 510(k) clearances on record.