# K081437: Mac 1600 Ecg Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Jul 15, 2008 after 54 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 K903644 (1991). 8 ancestors in all.
5 later devices descend 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)
- K973403: Cardiosmart ST, Marquette Medical Systems, Inc. (1998) Summary page 2.
- K031561: Cardiosoft/Case Cardiac Testing System, Ge Medical Systems Information Technologies (2003) Summary page 2.

## Most influential descendants
- K090212: Mac 800 Resting Ecg Analysis System (2009), 4 descendants of its own
- K133622: Mac 2000 Ecg Analysis System (2014), 1 descendant of its own
- K230834: CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H (2023), 0 descendants of its own
- K142288: MAC 800 Resting ECG Analysis System (2014), 0 descendants of its own
- K140020: Hyperq Acs-100 System (2014), 0 descendants of its own

## Indications for use
The MAC1600 is a portable ECG acquisition, analysis and recording system. The MAC1600 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC1600 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The basic system shall provide 2 modes of operation: (1) Resting ECG mode and (2) Arrhythmia mode. The basic systems shall print 6 or 12-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. The basic system shall be upgradeable with a third mode of operation: (3) Exercise mode for exercise stress testing. Transmission and reception of ECG data to and from a central ECG cardiovascular information system shall be optional. The arrhythmia detection portion of the MAC 1600 is provided to the customer for the convenience of automatic documentation. The MAC 1600 is used under the direct supervision of a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K081437
Methodology: https://510kreport.com/methodology