# K042177: Modification to Mac 5000 Ecg Analysis System

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Aug 27, 2004 after 16 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: 5 generations back to K921669 (1993). 10 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033492: Modification to Mac 5000 Ecg Analysis System, Ge Medical Systems Information Technologies (2003) Summary page 1.

## Most influential descendants
- K060833: 12SL Ecg Analysis Program (2006), 21 descendants of its own
- K092369: 12SL Ecg Analysis Program (2010), 19 descendants of its own
- K133882: Carescape Central Station (Formally Known as Cic Pro) (2014), 9 descendants of its own
- K162012: CARESCAPE Central Station V2 (2016), 7 descendants of its own
- K073625: Modification to: Mac 5500 Resting Ecg Analysis System (2008), 7 descendants of its own

## Indications for use
The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution 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 MAC 5000 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/K042177
Methodology: https://510kreport.com/methodology