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M3290B Patient Information Center iX

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K183387

by Philips Medical Systems

Identifiers

510(k) Number
K183387 FDA 510(k)
FDA Product Code
MHX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1025 FDA 510(k)
Regulation Number
870.1025 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The M3290B Patient Information Center iX is a Physiological Monitor, Patient (with Arrhythmia Detection or Alarms) designed to aggregate and display patient vital signs and clinical data from multiple sources. It consolidates real-time monitoring information, including ECG, heart rate, and arrhythmia alerts, to support comprehensive patient observation in diverse care settings.

This system is intended for use in hospital, clinic, or intensive care environments, where it interfaces with both Philips and third-party monitoring devices to centralize patient data. Supplied as a reusable, non-sterile device, it operates within standard electromagnetic safety guidelines and requires proper calibration and maintenance. Authorized under FDA 510(k) clearance and MDD compliance, it adheres to regulatory standards for cardiovascular monitoring systems.

Frequently asked questions

What types of clinical environments is the M3290B Patient Information Center iX designed to support, and how does it integrate with other devices?

The M3290B is designed for use in hospital, clinic, and intensive care settings where continuous patient monitoring is critical. It aggregates and displays real-time vital signs—such as ECG, heart rate, and arrhythmia alerts—from multiple sources, including both Philips and third-party monitoring devices. This centralization of data allows clinicians to observe patients comprehensively across diverse care settings.

Is the M3290B Patient Information Center iX intended for single-use or reusable applications, and what does this mean for maintenance?

The M3290B is supplied as a reusable, non-sterile device. This means it is designed for repeated use within a clinical setting, but it requires proper calibration and maintenance to ensure accurate performance and compliance with electromagnetic safety guidelines over time.

What regulatory pathways has the M3290B Patient Information Center iX followed, and what does this indicate about its compliance standards?

The device has been authorized through FDA 510(k) clearance and complies with the Medical Device Directive (MDD). The FDA clearance under a traditional 510(k) pathway and the MDD compliance indicate that it meets regulatory standards for cardiovascular monitoring systems, including safety, performance, and electromagnetic compatibility requirements.

Does the M3290B Patient Information Center iX support compatibility with a wide range of monitoring devices, and if so, how is this verified?

Yes, the M3290B is designed to interface with both Philips and third-party monitoring devices, as indicated by the extensive list of registration numbers under its OpenFDA entry. This compatibility is verified through regulatory submissions and testing to ensure seamless data aggregation and display of vital signs, including ECG and arrhythmia alerts, from diverse sources.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Patient Information Center iX (PIC iX) | Philips - Philips, PDF Patient Information Center iX - documents.philips.com, Patient Information Center iX (PIC iX) | Philips

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems

Sources (2)

  • FDA 510(k) K183387 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026