510(k) K232661

Myocardial Strain Software Application by Circle Cardiovascular Imaging — Product Code LLZ

K232661 is an FDA 510(k) premarket notification submitted by Circle Cardiovascular Imaging for the device "Myocardial Strain Software Application". The FDA issued a decision of Substantially Equivalent on December 7, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Circle Cardiovascular Imaging has at least 10 other 510(k) clearances on record.