# K183387: M3290B Patient Information Center iX

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Aug 6, 2019 after 243 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K941811 (1994). 138 ancestors in all.
No later device cites it as a predicate yet.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163584: M3290B Philips IntelliVue Information Center iX, Philips Medical Systems (2017) Summary page 6.

## Indications for use
The intended use of the Philips Patient Information Center iX software application is to: Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than at the patient, for multiple patients. Determine alarm conditions and generate alarm signals for Philips approved medical devices, that send physiological data and do not have the ability to determine the alarm condition. Algorithms present in the software are limited to the ST/AR ECG (for arrhythmia, ST Segment and QT Segment Monitoring) and SpO2. Generate alarm signals for user notification, based on the alarm signal determined and sent by Philips approved medical devices. Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices. Provide review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required. Provide connection to other systems not associated with active patient monitoring, such as information systems. The software performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data. The Information Center Software is intended for use in professional healthcare facilities by trained healthcare professionals. The Information Center Software is not intended for home use. Indicated for use when monitoring adult and/or specified pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data. Rx only.

Source page: https://510kreport.com/device/K183387
Methodology: https://510kreport.com/methodology