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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 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.

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. The listed applicant is Heartbeam, Inc.. The 510(k) number is K250258.

When did HeartBeam AIMIGo with 12-L ECG Synthesis Software System receive FDA 510(k) clearance?

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

Who is the listed applicant for HeartBeam AIMIGo with 12-L ECG Synthesis Software System?

The FDA 510(k) record lists Heartbeam, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Heartbeam, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231424HeartBeam AIMIGo(TM) System

Related Devices (Code: DXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.K222842V-Patch Cardiac MonitorShandong Corecare Technology Limited

Official Source

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

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