# K991014: Case 8000 Exercise Testing System

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Oct 20, 1999 after 208 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K903644 (1991). 4 ancestors in all.
33 later devices descend from it; 3 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)
- K951130: Cardiosoft/Cardiosys, Marquette Electronics, Inc. (1996). Our OCR of the scanned summary read K251130, FDA’s number for Portable Oxygen Concentrator (JM-P50A) (Jiangsu Jumao X-Care Medical Equipment Co., Ltd.), decided Aug 21, 2025, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CardioSoft/CardioSys”.
- K973403: Cardiosmart ST, Marquette Medical Systems, Inc. (1998) Summary page 3.

## Most influential descendants
- K023380: T-Wave Altermans (Twa) Algorithm Option (2002), 31 descendants of its own
- K031561: Cardiosoft/Case Cardiac Testing System (2003), 30 descendants of its own
- 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

## Indications for use
The CASE 8000 exercise testing system is a diagnostic device intended to monitor and record electrocardiographic data from the patient during exercise, as well as perform resting ECG analysis. The intended use of the CASE 8000 exercise testing system is to acquire, process. record, archive, analyze. and output data during a period of physiologic stress or during a resting ECG condition. The CASE 8000 exercise testing system has the ability to calculate prognostic scores. A user selectable option can provide printout of prognostic scores’on select reports. A vector loops report is also available. Ancillary functions include control of an extemal device (typically a treadmill or ergometer) and comrmunications with centralized electronic/digital storage system. This device uses a computerized analysis program, which can be used as a tool in ECG tracing interpretation. The device records 12 lead ECG data taken in resting and exercise modes, as well as real-time rhythm and median morphology recordings. The device can perform a 12 lead interpretive analysis oh the resting ECG, providing the user with statements of momphology, rhythm and conduction. The CASE 8000 exercise testing system is intended to be used by trained operators under the direct supervision of a licensed health care practitioner when exercise or resting ECG records are required, The CASE 8000 exercise testing system is intended to be used primairily in hospital based exercise testing iaboratories, but can be used in clinics, physician offices, outreach centers or wherever exercise testing is performed. This device is not infended for use with high frequency surgical units. The CASE 8000 system is not intended to be used as a vital signs physiological monitor. This equipment will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulator.

Source page: https://510kreport.com/device/K991014
Methodology: https://510kreport.com/methodology