# K103678: Case Cardiac Testing System, CS Cardiac Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies GmbH
- Decided: Feb 16, 2011 after 62 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: 5 generations back to K903644 (1991). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031561: Cardiosoft/Case Cardiac Testing System, Ge Medical Systems Information Technologies (2003) Summary page 1.

## Most influential descendants
- K231870: CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System (2023), 0 descendants of its own

## Indications for use
The CASE Cardiac Testing System and CS Cardiac Testing System are designed to be used for resting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CASE isa turnkey product utilizing the CS software. The CS will be offered as a software only package including a front end for data acquisition. CASE Cardiac Testing System and CS Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CASE Cardiac Testing System and CS Cardiac Testing System are 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 from 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 CASE Cardiac Testing System and CS Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. CASE Cardiac Testing System and CS Cardiac Testing System provide the control of external devices (typically a treadmill or Ergometer) and communicate with centralized electron ic/dig italI storage system via network. CASE Cardiac Testing System and CS Cardiac Testing System provide a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available. CASE Cardiac Testing System and CS Cardiac Testing System can be configured in a network environment for multiple CASE stations and CS stations allowing the user to create a central database of patient demographics and collected patient physiological data. CASE Cardiac Testing System and CS Cardiac Testing System are 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. CASE Cardiac Testing System and CS Cardiac Testing System offer no diagnostic opinion to the user. instead it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion. CASE Cardiac Testing System and CS Cardiac Testing System are not intended to be used as a transport device or for home use. CASE Cardiac Testing System anid CS Cardiac Testing System are not intended for the use as a vital signs physiological monitor or for intracardiac use.

Source page: https://510kreport.com/device/K103678
Methodology: https://510kreport.com/methodology