# Heartbeam, Inc.

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 2 (2024–2025): 2 510(k) clearances
- Product codes: DXH (1), MWJ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Paceart, Inc.: 1 (https://510kreport.com/company/paceart)
- AliveCor, Inc.: 1 (https://510kreport.com/company/alivecor)

## Recent decisions
- K250258: HeartBeam AIMIGo with 12-L ECG Synthesis Software System (Dec 8, 2025)
- K231424: HeartBeam AIMIGo (TM) System (Dec 13, 2024)

Source page: https://510kreport.com/company/heartbeam