# K081983: M3290A Intellivue Information Center Software, Release 1.00

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Aug 22, 2008 after 42 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K941811 (1994). 133 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062271: M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170), Philips Medical Systems (2006) Summary page 1.
- K050742: M3290A Intellivue Information Center Software Release G.00, Philips Medical Systems (2005) Summary page 1.
- K041741: M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry System II Including M4841A Patien, Philips Medical Systems, Inc. (2004) Summary page 1.
- K040955: M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical Network on Vlan, Philips Medical Systems, Inc. (2004) Summary page 1.
- K040357: M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry Monitoring System II, Philips Medical Systems, Inc. (2004) Summary page 1.
- K031403: M3290A Intellivue Information Center Software Release E.1, Philips Medical Systems, Inc. (2003) Summary page 1.
- K023698: M3290A Intellivue Information Center Software Release E.O, Philips Medical Systems (2002) Summary page 1.
- K021422: Philips Information Center Software Revision D.02, Philips Medical Systems (2002) Summary page 1.
- K011093: Agilent Information Center Software for M3150,M3151,M3153 and M3154, Agilent Technologies, Inc. (2001) Summary page 1.
- K001057: Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4 Compact Portable Patient Monitor, Agilent Technologies, Inc. (2000) Summary page 1.
- K000854: Viridia Information Center Software for M3150A and M3153A, Viridia Telemetry System Transmitter, Agilent Technologies, Inc. (2000) Summary page 1.
- K993907: Viridia Information Center Software for M3154A Opt C22, Agilent Technologies, Inc. (1999) Summary page 1.
- K993171: HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154A, Hewlett-Packard Co. (1999) Summary page 1.
- K964832: Hewlett-Packard Centralvue Software, Hewlett-Packard Co. (1997) Summary page 1.

## Most influential descendants
- 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
- K153702: M3290B Philips IntelliVue Information Center iX (2016), 3 descendants of its own
- K163584: M3290B Philips IntelliVue Information Center iX (2017), 2 descendants of its own
- K131032: Philips Suresigns Central (2013), 1 descendant of its own

## Recalls of this device
- Nov 9, 2012 · Class II · Z-0495-2013: Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.
- May 3, 2011 · Not classified · Z-2217-2011: PAS-210 Kit Remote Active Speaker Assembly used with the IntelliVue Information CenterSpeaker cable connection may lead to intermittent or loss of audio alarm annunciation
- Dec 17, 2010 · Not classified · Z-0987-2011: Some PAS-201 active speaker assemblies in use with the Philips IntelliVue Information Center (PIIC) have experienced intermittent audio or loss of audio. Speaker failures may delay recognition of an a

## Indications for use
Indicated 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/K081983
Methodology: https://510kreport.com/methodology