# K060307: 12 RL Algorithm

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Aug 4, 2006 after 178 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K946306 (1995). 33 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992595: HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement, HP Viridia CMS 24/26, Rev K with, Hewlett-Packard GmbH (1999) Summary page 1.
- K030738: Siemens Multiview Infinity Telemetry System, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K964750: Eagle 4000 Patient Monitor, Marquette Electronics, Inc. (1997) Summary page 1.

## Most influential descendants
- K101521: ST/AR ST and Arrhythmia Software Model: Release K.O (2010), 4 descendants of its own
- K150352: V Series Monitoring System (including V12 and V21 Monitors) (2015), 1 descendant of its own
- K153448: Passport Series Patient Monitors (Including Passport 8, Passport 12) (2016), 0 descendants of its own
- K151812: Patient Monitors Various Models (2016), 0 descendants of its own
- K150082: Panorama Patient Monitoring Network (2015), 0 descendants of its own

## Indications for use
The GE 12RL program generates a 12-lead ECG report from a subset of the electrodes used to acquire a standard '12 lead ECG. Four of the precordial channels of the 12-lead ECG (V2, V3, V4, V6) are not acquired from the patient; rather, they are reconstructed from information that is directly recorded in the other channels of the 12-lead ECG. The four signals generated by the GE 12RL program are similar but not identical to the standard 12-lead ECG. All ECG data generated via 12RL are clearly identified as to which channels have been synthesized. The GE 12RL program is intended for use in a monitoring environment. Computerized measurements may be generated from these data; however, a computerized interpretation will not. The product is intended for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The product is to be uscd in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment.

Source page: https://510kreport.com/device/K060307
Methodology: https://510kreport.com/methodology