# K022297: Global Ecg Management System (Gems)

- Pathway: 510(k) (Special)
- Applicant: Cardiocomm Solutions, Inc.
- Decided: Sep 27, 2002 after 73 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K945626 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982384: Mercator, Harley Street Software, Ltd. (1999) Summary page 1.
- K020366: Global Ecg Management System (Gems), Cardiocomm Solutions, Inc. (2002) Summary page 1.

## Indications for use
GEMS is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices, including diagnostic 12-lead devices. Users will be able to purchase specific modules for managing other patient cardiac related data such as pacemaker and rehabilitation data that fit their patients' needs. The ECG module may be licensed to other software developers as an ECG viewer for their products, GEMS is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate, GEMS does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data. This version of GEMS includes the EASl algorithm far deriving an approximation to a 72-lead ECG from a 3-chann,el recording (using the lead placement specified in the EASlTrak 12 Model 4100 I Zyrned Model 4100 / EASl Arrhythmia Event Monitor user manual). If manual ST segment measurements will be made on the approximated 12-lead ECG, the patient population is limited to the following indications: Ages: 33 to 82 years Heights: 147 to 185 cm (58 to 73 in) Weights: 53 to 'I18 kg (1 17 to 261 Ib) Height to Weight ratios: 1.41 to 2.99 crnlkg (0.25 to 0.54 inllb)

Source page: https://510kreport.com/device/K022297
Methodology: https://510kreport.com/methodology