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Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse O

by GE Medical Systems Information Technologies, Inc.

510(k) K234130

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K234130↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK234130 Date20 Mar 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

4 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3036-2026 FDA Class II initiated 20 Jul 2026
    • Ongoing Z-3037-2026 FDA Class II initiated 20 Jul 2026

    Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

    • Ongoing Z-2878-2026 FDA Class II initiated 10 Jul 2026

    Portrait Core Services Software version V1.2.0 Security Vulnerability

    • Ongoing Z-0918-2025 FDA Class II initiated 6 Dec 2024

    There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MWI
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Portrait Mobile Monitoring Solution is a wireless patient monitoring system designed for continuous, non-invasive vital sign assessment. It integrates hardware, software, and wearable sensors to provide real-time monitoring of physiological parameters such as pulse oximetry, enabling clinical decision support in diverse healthcare settings.

This solution comprises a central viewer application, core services, clinical alarming unit, mobile patient monitor hardware and software, and two wearable pulse oximetry sensors (SpO₂ P-SA01 and SpO₂ P-SP01). Supplied as a modular system, it is intended for single-use components where applicable, with regulatory authorisations including FDA 510(k) clearance under the Cardiovascular advisory committee and MDR compliance. The system is intended for use in acute and critical care environments, adhering to standard medical device safety and sterility protocols.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of sensors are included in the Portrait Mobile Monitoring Solution, and how are they used?

    The Portrait Mobile Monitoring Solution includes two wearable pulse oximetry sensors: the Portrait SpO₂ P-SA01 and Portrait SpO₂ P-SP01. These sensors are designed for non-invasive, continuous monitoring of oxygen saturation (SpO₂) and pulse rate, providing real-time physiological data to support clinical decision-making in acute and critical care settings. The sensors are part of a wireless system that integrates with the mobile patient monitor hardware and software for seamless monitoring.

  • Are the wearable sensors in the Portrait Mobile Monitoring Solution intended for single-use or reusable applications?

    The wearable pulse oximetry sensors (SpO₂ P-SA01 and SpO₂ P-SP01) in the Portrait Mobile Monitoring Solution are explicitly designed for single-use applications. This aligns with standard medical device safety and sterility protocols to ensure patient safety and reduce infection risks in clinical environments.

  • What regulatory pathways has the Portrait Mobile Monitoring Solution followed, and which advisory committee was involved?

    The Portrait Mobile Monitoring Solution has undergone regulatory review through the FDA 510(k) pathway, specifically under the Cardiovascular (CV) advisory committee. It was determined to be substantially equivalent to a predicate device, with clearance granted on March 20, 2024. Additionally, the solution complies with MDR (Medical Device Regulation) requirements, ensuring adherence to both U.S. and EU regulatory standards.

  • How is the Portrait Mobile Monitoring Solution structured in terms of hardware and software components?

    The Portrait Mobile Monitoring Solution is a modular system combining multiple hardware and software components: the Portrait Central Viewer Application (Portrait CVAXB), Portrait Core Services (Portrait CSSXB), Portrait Clinical Alarming Unit (Portrait CAU01), Portrait Mobile Patient Monitor Hardware (Portrait HUBXB), Portrait Mobile Patient Monitor Software (Portrait HSWXB), and the two wearable pulse oximetry sensors. This integration enables wireless, real-time monitoring of vital signs in diverse healthcare settings.