# K251670: MAC 7 Resting ECG Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Jan 26, 2026 after 241 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K933143 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203786: MAC 7 - Resting ECG Analysis System, Ge Medical Systems Information Technologies, Inc. (2021) Summary page 6.

## Indications for use
The MAC 7 Resting ECG Analysis System is a non-invasive prescription device. • The device is indicated for use to acquire, analyze, display and print electrocardiograms. • The device is indicated for use to provide interpretation of the data for consideration by a physician. • The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. • The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. • The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.

Source page: https://510kreport.com/device/K251670
Methodology: https://510kreport.com/methodology