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— 510(k) K234130
Substantially EquivalentGe Medical Systems Information Technologies, Inc.
FDA 510(k) clearance K234130 for 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, Substantially Equivalent on 2024-03-20. Applicant: Ge Medical Systems Information Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies, Inc.
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wauwatosa, WI, US
Recent devices under product code MWI
view allMore clearances from Ge Medical Systems Information Technologies, Inc.
view all- K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- K251670 — MAC 7 Resting ECG Analysis System
- K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
- K233810 — Portrait VSM
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K234130
K-number listed on FDA's recall record- Z-3037-2026 — PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
- Z-3036-2026 — PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
- Z-2878-2026 — GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
- Z-0918-2025 — Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K234130.
Data sourced from openFDA. This site is unofficial and independent of the FDA.