HeartBeam AIMIGo with 12-L ECG Synthesis Software System

HeartBeam AIMIGo with 12-L ECG Synthesis Software System is the device name listed in this FDA 510(k) record. The listed applicant is Heartbeam, Inc.. It received FDA 510(k) clearance on 2025-12-08 under 510(k) number K250258. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.