# K050731: Seer Light Extend Compact Digital Holter System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: May 19, 2005 after 59 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- 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: 2 generations back to K001317 (2000). 2 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021470: Seer Light Compact Digital Holter Recorder, General Electric Medical Systems Information Techn (2002) Summary page 1.

## Most influential descendants
- K112921: Medicalgorithmics Unified Arrhythmia Diagnostic System (2012), 7 descendants of its own
- K124060: Medical Gorithmics Unified Arrhythmia Diagnostic System (2013), 5 descendants of its own
- K152550: Medicalgorithmics Unified Arrhythmia Diagnosic System (2015), 3 descendants of its own
- K200833: RX-1 Rhythm Express Remote Cardiac Monitoring System (2020), 1 descendant of its own
- K241179: Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) (2025), 0 descendants of its own

## Indications for use
The SEER Light Extend Compact Digital Holter Recorder and Controller System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric and adult patients. The device stores this data along with patient demographic information to on board flash memory. The SEER Light Extend Compact Digital Holter System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility. The SEER Light Extend Compact Digital Holter System does not perform any analysis of the ECG data. The SEER Light Extend Compact Digital Holter System is not intended for use on patients weighing less than 10Kg.

Source page: https://510kreport.com/device/K050731
Methodology: https://510kreport.com/methodology