# K030145: Galix Winter

- Pathway: 510(k) (Traditional)
- Applicant: Galix Biomedical Instrumentation, Inc.
- Decided: Sep 17, 2003 after 245 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The GALIX WinTer ECG Holter Analysis system is intended for patients requiring 24hr ambulatory monitoring. It is indicated for use in: the replay, analysis, display, editing and report generation of ambulatory ECG data the assessment of cardiac disturbance and myocardial ischemia

Source page: https://510kreport.com/device/K030145
Methodology: https://510kreport.com/methodology