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IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 +2 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K171801

by Philips Medizin Systeme Boeblingen GmbH

Identifiers

510(k) Number
K171801 FDA 510(k)
FDA Product Code
MHX FDA 510(k)
Models / Variants
IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 FDA 510(k)EUDAMED
intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension FDA 510(k)EUDAMED
Transpac IV Dual IBP Cable FDA 510(k)EUDAMED

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 IntelliVue Patient Monitor MX100 is a physiological patient monitor designed for continuous, non-invasive monitoring of vital signs, including arrhythmia detection and alarms. It integrates with modular extensions such as the Hemodynamic, Capnography, and Microstream modules to provide advanced hemodynamic monitoring, capnography, and microstream blood gas analysis, respectively. The device supports real-time patient assessment in critical care settings, including intensive care units and operating rooms, where precise and reliable monitoring is essential.

The system is supplied as a reusable monitor with modular, reusable extensions and disposable accessories, including the Transpac IV Dual IBP Cable for invasive blood pressure monitoring. It is intended for use in environments where MRI safety is not required, as specified. The device holds FDA 510(k) clearance and EU MDR authorization, adhering to regulatory standards for cardiovascular monitoring. Storage and handling follow manufacturer guidelines to ensure device integrity and performance.

Frequently asked questions

What types of monitoring capabilities does the IntelliVue Patient Monitor MX100 provide, and how does it integrate with additional modules?

The IntelliVue Patient Monitor MX100 continuously monitors vital signs, including heart rhythm and arrhythmias, with built-in alarms for real-time patient assessment. It integrates with modular extensions like the Hemodynamic Extension for advanced cardiovascular monitoring, the Capnography Extension for respiratory assessment, and the Microstream Extension for microstream blood gas analysis. These extensions expand its functionality for critical care environments such as ICUs and operating rooms.

Are the IntelliVue Patient Monitor MX100 and its extensions reusable, or are there disposable components involved?

The IntelliVue Patient Monitor MX100 itself and its modular extensions (Hemodynamic, Capnography, Microstream) are reusable. However, the system includes disposable accessories, such as the Transpac IV Dual IBP Cable for invasive blood pressure monitoring, which must be replaced after each use to maintain sterility and performance.

What regulatory pathways has the IntelliVue Patient Monitor MX100 followed, and where is it authorized for use?

The device holds FDA 510(k) clearance, demonstrating it is substantially equivalent to a predicate device under the U.S. regulatory pathway. It also carries EU MDR authorization, confirming compliance with European Union medical device regulations. These authorizations validate its use in both the U.S. and the EU markets.

Can the IntelliVue Patient Monitor MX100 be used in environments where MRI compatibility is required?

No, the IntelliVue Patient Monitor MX100 is explicitly designed for use in environments where MRI safety is not required. This means it should not be used near MRI machines or in areas where electromagnetic interference from MRI systems could affect its operation or pose a risk to patients.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medizin Systeme Boeblingen GmbH

Sources (2)

  • FDA 510(k) K171801 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026