# K023698: M3290A Intellivue Information Center Software Release E.O

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Nov 19, 2002 after 15 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K964832 (1997). 3 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993907: Viridia Information Center Software for M3154A Opt C22, Agilent Technologies, Inc. (1999) Summary page 1.

## Most influential descendants
- K040955: M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical Network on Vlan (2004), 10 descendants of its own
- K062271: M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) (2006), 9 descendants of its own
- K081983: M3290A Intellivue Information Center Software, Release 1.00 (2008), 8 descendants of its own
- K102495: M3290B Intellivue Information Center Software, Release a.0 (2010), 7 descendants of its own
- K143057: M3290B Philips IntelliVue Information Center iX (2014), 4 descendants of its own

## Recalls of this device
- Nov 21, 2008 · Not classified · Z-0034-2011: Potential for Internal Sound Amplifier to malfunction which could delay treatment.

## Indications for use
For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Source page: https://510kreport.com/device/K023698
Methodology: https://510kreport.com/methodology