# K123466: Healthview Ecg Manager

- Pathway: 510(k) (Traditional)
- Applicant: Lumedx
- Decided: Dec 20, 2012 after 41 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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 K842308 (1984). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052883: Cardioserver, Datrix (2005) Summary page 1.
- K083639: Muse Cardiology Information System with Vmware, Ge Medical Systems Information Technologies (2009) Summary page 1.

## Indications for use
The Health View ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send and print ECGs and related digitized clinical. documents through the use of on-screen measurement and editing tools. The system receives fies (such as ECG, stress, or Hotter) from any compatible device, displaying such data to the clinician for analysis and review. The product does not modify the original ECG waveform and does not provide an automated ECG analysis.

Source page: https://510kreport.com/device/K123466
Methodology: https://510kreport.com/methodology