510(k) K242062

1CMR Pro by Mycardium AI Limited — Product Code LLZ

K242062 is an FDA 510(k) premarket notification submitted by Mycardium AI Limited for the device "1CMR Pro". The FDA issued a decision of Substantially Equivalent on November 15, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Mycardium AI Limited has at least 1 other 510(k) clearance on record.