# K102495: M3290B Intellivue Information Center Software, Release a.0

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Sep 30, 2010 after 30 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K941811 (1994). 134 ancestors in all.
7 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)
- K081983: M3290A Intellivue Information Center Software, Release 1.00, Philips Medical Systems (2008) Summary page 1.
- 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). Our reading of the summary gave K001093, FDA’s number for Candela SPTL-1B Pulsed Dye Laser (Candela Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “M3290A IntelliVue Information Center Software, Release L.0”. 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
- 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
- K183387: M3290B Patient Information Center iX (2019), 0 descendants of its own

## Recalls of this device
- Jan 3, 2018 · Class II · Z-0776-2018: Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Any subsequent attempt to perform these operation
- Nov 25, 2015 · Class II · Z-0856-2016: Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
- Nov 25, 2015 · Class II · Z-0857-2016: Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
- Nov 25, 2015 · Class II · Z-0858-2016: Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
- Dec 19, 2014 · Class II · Z-0374-2016: Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
- Mar 5, 2013 · Class II · Z-1783-2014: If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact
- 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.

## 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/K102495
Methodology: https://510kreport.com/methodology