# K031561: Cardiosoft/Case Cardiac Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Aug 1, 2003 after 74 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: 4 generations back to K903644 (1991). 7 ancestors in all.
30 later devices descend from it; 6 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991014: Case 8000 Exercise Testing System, General Electric Medical Systems Information Techn (1999) Summary page 1.
- K951130: Cardiosoft/Cardiosys, Marquette Electronics, Inc. (1996) Summary page 1.
- K023380: T-Wave Altermans (Twa) Algorithm Option, General Electric Medical Systems Information Techn (2002)
- K002209: GE Marquette Ecg Analysis Program, General Electric Medical Systems Information Techn (2000)

## Most influential descendants
- K092010: PC Ecg, Model SE-1010 (2009), 18 descendants of its own
- K102854: PC ECG (2010), 13 descendants of its own
- K131819: PC ECG (2013), 12 descendants of its own
- K152427: PC ECG (2016), 11 descendants of its own
- K093869: SE-601 Series Electrocardiograph (2010), 10 descendants of its own

## Indications for use
CardioSoNCASE Cardiac Testing System is intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CardioSoWCASE Cardiac Testing System is designed to acquire process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data kom ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection. The arrhythmia detection portion of CardioSoWCASE Cardiac Testing System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. CardioSofKASE Cardiac Testing System provides the control of external device (typically a treadmill or Ergometer) and communicates with centralized electronic/digital storage system via network. CardioSofdCASE Cardiac Testing System provides a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available. CardioSofVCASE Cardiac Testing System can be configured in a network environment for multiple CASE and CardioSoft stations allowing the user to create a central database of patient demographics and collected patient physiological data. CardioSoWCASE Cardiac Testing System is intended to be used primarily in the hospital but can be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed. CardioSoNCASE Cardiac Testing System offers no diagnostic opinion to the user. Instead it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders hisher own medical opinion. CardioSoNCASE Cardiac Testing System is not intended to be used as a transport device or for home use. CardioSoWCASE Cardiac Testing System is not intended for the use as a vital signs physiological monitor or for intracardiac use.

Source page: https://510kreport.com/device/K031561
Methodology: https://510kreport.com/methodology