# K092369: 12SL Ecg Analysis Program

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Feb 24, 2010 after 203 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: 7 generations back to K921669 (1993). 12 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060833: 12SL Ecg Analysis Program, Ge Medical Systems Information Technologies (2006) Summary page 1.

## Most influential descendants
- K133882: Carescape Central Station (Formally Known as Cic Pro) (2014), 9 descendants of its own
- K162012: CARESCAPE Central Station V2 (2016), 7 descendants of its own
- K141963: 12SL Ecg Analysis Program (2015), 6 descendants of its own
- K201941: Monitor B125, Monitor B105 (2020), 3 descendants of its own
- K213490: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P (2022), 2 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. Interpretation by the product is then 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. ACS Tool option is intended for adult patient population who are suspected clinically to have acute coronary syndrome.

Source page: https://510kreport.com/device/K092369
Methodology: https://510kreport.com/methodology