# K060833: 12SL Ecg Analysis Program

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Aug 1, 2006 after 127 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: 6 generations back to K921669 (1993). 11 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042177: Modification to Mac 5000 Ecg Analysis System, Ge Medical Systems Information Technologies (2004) Summary page 1.
- K002209: GE Marquette Ecg Analysis Program, General Electric Medical Systems Information Techn (2000) Summary page 1.

## Most influential descendants
- K092369: 12SL Ecg Analysis Program (2010), 19 descendants of its own
- 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

## Indications for use
The 12SL ECG Analysis System with Right Ventricular Analysis assists the physician in interpreting resting 12-lead ECGs for rhythms 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 patient's homes.

Source page: https://510kreport.com/device/K060833
Methodology: https://510kreport.com/methodology