510(k) K234130 · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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 Monito
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Mar 20, 2024 |
| Received | Dec 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234130
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 Open, Classified |
MWI | None listed |
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 Open, Classified |
MWI | None listed |
| Aug 4, 2026 | GE Medical Systems Information Technologies Inc GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592 Open, Classified |
MWI | None listed |
| Jan 15, 2025 | GE Medical Systems, LLC 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 facil Open, Classified |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.