# K250258: HeartBeam AIMIGo with 12-L ECG Synthesis Software System

- Pathway: 510(k) (Traditional)
- Applicant: Heartbeam, Inc.
- Decided: Dec 8, 2025 after 314 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930806 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982090: Paceart Home Trak Plus Easi Event Recorder System, Paceart, Inc. (1999) Summary page 6.

## Indications for use
HEARTBEAM AIMIGo SYSTEM: The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional. HEARTBEAM 12-L ECG SYNTHESIS SOFTWARE: The HeartBeam 12-L ECG Synthesis Software synthesizes a 12-L ECG from the HeartBeam AIMIGo 3-Leads (in three-directions) recording device, producing a visual 12-L ECG representation that is similar, but not identical, to the same leads of a standard diagnostic 12-L ECG. The synthesized 12-L ECG output is solely intended for manual assessment of normal sinus rhythm and the following non-life-threatening arrhythmias: sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. The synthesized 12-L ECG output is not intended for the assessment of any other arrhythmia or conditions (including but not limited to: other atrial arrhythmias, ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction or ischemia, pacemaker functions, localization of arrhythmia foci, ECG wave abnormalities, and/or any other disorder). The software does not conduct cardiac analysis and is not intended to replace a standard 12-L ECG. The 12-L ECG Synthesis Software is intended for adult use only.

Source page: https://510kreport.com/device/K250258
Methodology: https://510kreport.com/methodology