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FDA 510(k)

HeartBeam AIMIGo with 12-L ECG Synthesis Software System

K-Number: K250258 · 2025-12-08

ApplicantHeartbeam, Inc.
Decision Date2025-12-08
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HeartBeam AIMIGo with 12-L ECG Synthesis Software System is a medical device manufactured by Heartbeam, Inc.. It received FDA 510(k) clearance on 2025-12-08 under approval 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.

Frequently Asked Questions

What is the HeartBeam AIMIGo with 12-L ECG Synthesis Software System?

HeartBeam AIMIGo with 12-L ECG Synthesis Software System is a medical device that received FDA 510(k) clearance on 2025-12-08. It is manufactured by Heartbeam, Inc.. The 510(k) number is K250258.

When was HeartBeam AIMIGo with 12-L ECG Synthesis Software System approved by the FDA?

HeartBeam AIMIGo with 12-L ECG Synthesis Software System received FDA 510(k) clearance on 2025-12-08, under approval number K250258.

What company makes HeartBeam AIMIGo with 12-L ECG Synthesis Software System?

HeartBeam AIMIGo with 12-L ECG Synthesis Software System is manufactured by Heartbeam, Inc..

What is the FDA product code for HeartBeam AIMIGo with 12-L ECG Synthesis Software System?

The FDA product code for HeartBeam AIMIGo with 12-L ECG Synthesis Software System is DXH. This falls under the Hematology category.

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Other Devices by Heartbeam, Inc.

K231424HeartBeam AIMIGo(TM) System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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