# K091176: Philips Telemedicine Server/System, Model 861441

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Nov 13, 2009 after 205 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- 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
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. The FDA summary names its predicate without a number.
- (no number) Philips HeartStart 12 Lead Transfer Station: named in the summary without a submission number

## Indications for use
The HeartStart Telemedicine Server software displays patient vitals, waveforms and 12-lead ECG information transmitted from Philips HeartStart defibrillators in remote locations. The HeartStart Telemedicine server allows viewing, diagnostic quality printing, archiving and further distribution of digitized clinical data. The HeartStart Telemedicine Server is also able to forward the 12-lead ECG information into ECG management systems that can process XML format ECG reports such as the TraceMasterVue ECG Management System

Source page: https://510kreport.com/device/K091176
Methodology: https://510kreport.com/methodology