# K014108: Mac 5000 Ecg Analysis System

- Pathway: 510(k) (Special)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Jan 10, 2002 after 28 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: 3 generations back to K921669 (1993). 8 ancestors in all.
71 later devices descend from it; 6 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991735: Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8 Electrocardiographs, General Electric Medical Systems Information Techn (1999) Summary page 1.
- K002209: GE Marquette Ecg Analysis Program, General Electric Medical Systems Information Techn (2000) Summary page 1.
- K974199: Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (Aci-Tipi) Option, Marquette Medical Systems, Inc. (1998) Summary page 1.
- K890323: Max-1 (Exercise Electrocardiograph), Marquette Electronics, Inc. (1989) Summary page 1.

## Most influential descendants
- K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200 (2009), 32 descendants of its own
- K033492: Modification to Mac 5000 Ecg Analysis System (2003), 31 descendants of its own
- K042177: Modification to Mac 5000 Ecg Analysis System (2004), 30 descendants of its own
- K060833: 12SL Ecg Analysis Program (2006), 21 descendants of its own
- K092369: 12SL Ecg Analysis Program (2010), 19 descendants of its own

## Indications for use
The MAC 5000 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, 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/K014108
Methodology: https://510kreport.com/methodology