# K180157: QT ECG

- Pathway: 510(k) (Traditional)
- Applicant: QT Medical, Inc.
- Decided: May 4, 2018 after 105 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K963725 (1997). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113514: Smartheart, Shl Telemedicine International, Ltd. (2012) Summary page 4.

## Most influential descendants
- K220795: QT ECG (2022), 1 descendant of its own
- K233521: QT Ecg (QTERD100) (2023), 0 descendants of its own

## Indications for use
The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location. The QT ECG System is indicated for use on adult patients and pediatric patients age 18 — 22 years. It is designed to be used by a patient or other layperson in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), to record and transmit a 12-lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving centers.

Source page: https://510kreport.com/device/K180157
Methodology: https://510kreport.com/methodology