# K230626: 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™ - Pathway: 510(k) (Traditional) - Applicant: Ge Medical Systems Information Technologies, Inc. - Decided: Aug 11, 2023 after 157 days - Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)) - Device class: 2 - Regulation: 21 CFR 870.2300 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 20 generations back to K962603 (1997). 91 ancestors in all. 2 later devices descend from it; 2 cite it directly. 2 of 94 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K171121: Masimo Root Monitoring System and Accessories, Masimo Corporation (2017) Summary page 11. ## Most influential descendants - K240251: ANNE Chest (2024), 0 descendants of its own - K234130: 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 (2024), 0 descendants of its own ## Recalls of this device - Jul 20, 2026 · Class II · 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 ## Indications for use The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg). Physiological parameters and waveforms supported are: * Pulse oximetry (SpO2/pulse rate) * Respiration rate (RR) Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications. The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. This device is not an Apnea monitor (i.e., do not rely on the device for detection or alarm for the cessation of breathing). This device should not be used for life sustaining/supporting purposes. The Portrait Mobile Monitoring Solution is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait Central Viewer Application (Portrait CVAO01): The Portrait Central Viewer Application (Portrait CVAO1) provides monitoring station capability running as an application for the Portrait Mobile Monitoring Solution on a PC platform that meets minimum system requirements. It provides the ability to view real-time data for multiple patients and historical data for a single patient including configurable visual and audible alarm notifications. The Portrait Central Viewer Application is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Portrait Core Services (Portrait CSS01): The Portrait Core Services are a set of software services that enable the communication and interaction of the Portrait Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems. The Portrait Core Services can transmit patient physiological trends and numerics (IHE PCD DEC) and alarm events (IHE PCD ACM) outbound. The Portrait Core Services can also receive HL.7 ADT information to admit patients to the Portrait Monitoring Solution. Portrait Clinical Alarming Unit (Portrait CAUO1): The Portrait Clinical Alarming Unit (Portrait CAUO1) is a required accessory to the Portrait Central Viewer Application that provides audio alarming capability. The Portrait Clinical Alarming Unit is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Portrait Mobile Patient Monitor (Portrait HUB01): The Portrait Mobile Patient Monitor (Portrait HUBO1) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. The Portrait Mobile Patient Monitor enables non-invasive continuous monitoring of patients by acquiring signals from body-worn sensors through a Medical Body Area Network (MBAN) connection as well as displaying trends and events. The device can be configured to provide local audible and visual alarms and can also provide real-time, trend and event data to Portrait Core Services. The Portrait Mobile Patient Monitor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Mobile Patient Monitor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait Wearable Pulse Oximetry Sensor P-SAQ1 (Portrait SpO2 P-SA01): The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SPO01): The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) is intended for use with pediatric patients (3 years of age and older, and weighing 15 kg to 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SEO01): The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01, Portrait SpO2 P-W01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait SpO2 Attachment Accessory Band (Portrait AABO1): The Portrait SpO2 Attachment Accessory Band (Portrait AABO1) is intended to provide a means to secure the Portrait Wearable Pulse Oximetry Sensor with Portrait Sensor Battery to the patient’s wrist. The Portrait Attachment Accessory Band is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Portrait Wearable Respiration Rate Sensor (Portrait RR P-RR01): The Portrait Wearable Respiration Rate Sensor (Portrait P-RRO01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The Wearable Respiration Rate Sensor acquires parameter data from the patient and transmits it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Respiration Rate Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Respiration Rate Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait RR Electrode Patch (Portrait RRPO1): The Portrait RR Electrode Patch (Portrait RRP01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The electrode patch transfers carrier signals from the wearable respiration rate sensor and transfers impedance and biopotential signals from the patient and transmits them to the wearable respiration rate sensor. The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait RR Electrode Patch is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait Sensor Battery (Portrait SBTO1): The Portrait Sensor Battery (Portrait SBTO01) is intended for use as a power supply for the Portrait wearable sensors and to provide wireless communication to a host device. The Portrait Sensor Battery is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Sensor Battery is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait Bedside Charger (Portrait BCHO1): The Portrait Bedside Charger (Portrait BCHO1) is intended for charging the Portrait Sensor Batteries and the Portrait Mobile Patient Monitor (including while the Portrait Mobile Patient Monitor is in use). The Portrait Bedside Charger is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Bedside Charger is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait Mobile Patient Monitor Pouch (Portrait MMP01): The Portrait Mobile Patient Monitor Pouch (Portrait MMPO1) is an optional accessory intended to enable the Mobile Patient Monitor to be carried while the patient is ambulatory. The Portrait Mobile Patient Monitor pouch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Source page: https://510kreport.com/device/K230626 Methodology: https://510kreport.com/methodology