# K110266: Mac 5500 HD, Mac 3500

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Apr 29, 2011 after 91 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: 7 generations back to K921669 (1993). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073625: Modification to: Mac 5500 Resting Ecg Analysis System, Ge Healthcare Systems Information Technologies (2008) Summary page 1.

## Most influential descendants
- K152135: Quantitative Electrocardiographic Detector (QED 2000) (2016), 0 descendants of its own

## Indications for use
The MAC 5500 HD ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3.6, 12, or 15 lead ECG's, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolutions signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC5500 HD is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility. The MAC 3500 ECG Analysis System is intended to acquire, analyze, display, and record resting electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, including interpretive analysis. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 3500 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

Source page: https://510kreport.com/device/K110266
Methodology: https://510kreport.com/methodology