# K180432: AI-ECG Platform

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Carewell Electronics., Ltd.
- Decided: Nov 19, 2018 after 272 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921669 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113485: Electrocardiograph, Shenzhen Carewell Electronics Co., Ltd. (2012) Summary page 4.
- K052883: Cardioserver, Datrix (2005) Summary page 5.

## Indications for 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, 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. 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.

Source page: https://510kreport.com/device/K180432
Methodology: https://510kreport.com/methodology