# K141963: 12SL Ecg Analysis Program

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Feb 5, 2015 after 202 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K921669 (1993). 13 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092369: 12SL Ecg Analysis Program, Ge Medical Systems Information Technologies (2010) Summary page 4.

## Most influential descendants
- K231010: Corvair (2024), 1 descendant of its own
- K170155: EK12 Algorithm (2017), 1 descendant of its own
- K152993: MUSE Cardiology Information System (2016), 1 descendant of its own
- K252589: Corvair Monza (2026), 0 descendants of its own
- K221904: EK12 V2 Algorithm (2022), 0 descendants of its own

## Indications for use
The 12SL ECG Analysis Program assists the physician in measuring and interpreting resting 12-lead ECGs for rhythm and contour information by providing an initial automated interpretation. The interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients’ homes. The ACS Tool option is intended for adult patient populations who are suspected clinically to have acute coronary syndrome.

Source page: https://510kreport.com/device/K141963
Methodology: https://510kreport.com/methodology