Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™
by GE Medical Systems Information Technologies, Inc.
510(k) K230626
Active
Valid until
Not listed
FDA recalls
1 ongoingTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK230626 | Date11 Aug 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
-
- Ongoing Z-3038-2026
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.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- MWI
- Models / Variants
- 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
The Portrait System is a modular patient monitoring platform designed to integrate clinical alarms, patient data visualization, and wearable sensor connectivity. It includes a central viewer application for real-time monitoring, a clinical alarming unit for alert management, and a mobile patient monitor for portable patient assessment. Wearable pulse oximetry sensors enable non-invasive oxygen saturation and heart rate monitoring, while accessory bands ensure secure sensor attachment. The system supports interoperability between components for cohesive patient care workflows.
The Portrait System is supplied as a software-defined platform with hardware peripherals, including rechargeable sensor batteries, bedside chargers, and wearable pulse oximetry sensors. Components are intended for single-use (sensors) or reusable (hardware accessories) in clinical settings, with no MRI safety restrictions specified. The system operates under FDA 510(k) clearance and MDR compliance, with model-specific identifiers ensuring traceability. Storage and handling follow standard medical device protocols as defined by regulatory guidelines.
Other devices from GE Medical Systems Information Technologies, Inc.
See all devices from GE Medical Systems Information Technologies, Inc. →
Questions
AI-generated answers, 18 Sep 2026
What types of sensors are included in the Portrait System, and how are they intended to be used?
The Portrait System includes wearable pulse oximetry sensors (models Portrait SpO2 P-SA01, P-SP01, P-W01, and P-SE01) designed for non-invasive monitoring of oxygen saturation (SpO2) and heart rate. These sensors are intended for single-use in clinical settings and connect wirelessly to the system for real-time patient data visualization. The secure attachment is ensured using the reusable Portrait SpO2 Attachment Accessory Band (Portrait AAB01).
Are the hardware components of the Portrait System reusable, and if so, how should they be maintained?
Yes, the hardware components like the mobile patient monitor (Portrait HUB01), sensor battery (Portrait SBT01), and bedside charger (Portrait BCH01) are designed for reuse in clinical settings. Maintenance should follow standard medical device protocols, including cleaning and storage as defined by regulatory guidelines, though specific instructions are not detailed in the provided data.
How does the Portrait System ensure interoperability between its components, and what does this mean for clinical workflows?
The Portrait System is a modular platform with integrated software (Portrait CV A01 and Portrait CSS01) and hardware peripherals that are designed to work cohesively. This interoperability allows real-time monitoring, clinical alarm management, and portable patient assessment, streamlining workflows by centralizing patient data visualization and connectivity for wearable sensors like pulse oximetry.
What regulatory pathways does the Portrait System follow, and how does this impact its use in clinical settings?
The Portrait System is cleared under the FDA 510(k) pathway (K230626) and complies with the EU Medical Device Regulation (MDR). This means it has undergone evaluation for safety and performance, ensuring it meets regulatory standards for use in clinical settings. The system’s modular components are traceable via model-specific identifiers, supporting compliance and traceability requirements.
Are there any specific storage or handling requirements for the wearable sensors in the Portrait System?
While the data does not specify exact storage protocols for the wearable pulse oximetry sensors, standard medical device guidelines should be followed to ensure their integrity. Since these sensors are single-use, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use, adhering to general best practices for medical consumables.