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510(k) Data Aggregation

    K Number
    K252361

    Validate with FDA (Live)

    Device Name
    AccurECG Analysis System (v2.0)
    Manufacturer
    Accurkardia, Inc.
    Date Cleared
    2025-12-22

    (146 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    22 - 120
    Reference & Predicate Devices
    K223013
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AccurECG® Analysis System v2.0 is intended for use by qualified healthcare professionals in the assessment of a patient's recorded ambulatory ECG data. Analysis results are provided in a standard report for review and printing.

    The System provides single-lead analysis on a beat-by-beat basis, Ventricular Ectopic Beat and Supraventricular Ectopic Beat detection, heart rate measurement, and rhythm analysis. The AccurECG® Analysis System v2.0 is compatible with ECG recordings taken with silver/silver chloride (Ag / AgCl) electrodes (wet leads).

    The AccurECG® Analysis System v2.0 is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The System is not intended to be used with cardiac telemetry monitors.

    The AccurECG® Analysis System's automated interpretation results are not intended to be the sole means of diagnosis. The AccurECG Report is an adjunct intended to facilitate health care decision making in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information to arrive at a diagnostic conclusion.

    The AccurECG® Analysis System v2.0 does not interface with data management systems or hardware and is device independent.

    Device Description

    The AccurKardia ECG Analysis System consists of: (1) A client-side web interface which provides tools to upload and review ECG recordings via a web application programming interface (API), and (2) A server-side automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis.

    AccurECG v2.0 is intended to analyze recordings performed on adults aged 22 and older and works in the following sequence:

    i. The web interface allows the user to select files and upload to the AccurECG secure database.

    ii. The proprietary AccurECG algorithm analyzes and labels the ECG:

    • Delineation – detection of QRS complexes and T waves on the ECG signal through advanced signal processing and image-based techniques.
    • Abnormality labels – automated arrhythmia interpretation and statistical classification.

    iii. AccurECG® Analysis System v2.0 displays the resulting analysis and original ECG signal with reviewing tools in the web interface.

    iv. AccurECG® Analysis System v2.0 allows for preliminary comments summarizing the review before generating a report.

    AI/ML Overview

    N/A

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