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510(k) Data Aggregation
K Number
K180432Device Name
AI-ECG Platform
Manufacturer
Shenzhen Carewell Electronics., Ltd
Date Cleared
2018-11-19
(272 days)
Product Code
DQK, DPS
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Carewell Electronics., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AI-ECG Platform is designed to assist physicians in measuring and interpreting 12-lead resting ECG, and the interpretation by the analysis program may then be confirmed, edited by the physician. The program is intended for use by qualified healthcare professionals and other healthcare facilities for the assessment of common cardiac abnormalities, including arthythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. They are offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.
The AI-ECG Platform is qualified for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities.
The AI-ECG Platform is used with compatible resting ECG devices which can export ECG recordings in Carewell ECG, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using non-standard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid.
Device Description
The AI-ECG Platform (S Edition) is a software package which is a distributed ECG auto analysis system designed to assist physician in measuring and interpreting 12-lead resting ECG with AI algorithm, the interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The program is intended for use by qualified healthcare professionals in hospitals and other healthcare facilities for the assessment of common cardiac abnormalities, including arrhythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.
The Carewell AI-ECG Platform is intended to be used in conjunction with Carewell ECG device or compatible ECG can export Carewell proprietary ECG data, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using non-standard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid. The program receives ECG waveform data direct from device or user manually uploaded, analyzes ECG data and automatically interprets on the computer server, the ECG measurement, interpretation and waveform data are then downloaded to a PC based physician's diagnosis client application to allow physician review, modify and confirm the analysis statements, and print the report. The original ECG waveform data is stored permanently in the server computer securely.
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