Home / 510(k) Clearances / K234130

510(k) 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 by Ge Medical Systems Information Technologies, Inc. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2024
Date Received
December 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Ge Medical Systems Information Technologies, Inc.

  • K251670 — MAC 7 Resting ECG Analysis System (January 26, 2026)
  • K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (July 9, 2025)
  • K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client (December 12, 2024)
  • K233810 — Portrait VSM (April 25, 2024)
  • K231870 — CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System (December 13, 2023)
  • K230626 — Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (August 11, 2023)
  • K230145 — ONE-CUF (March 14, 2023)
  • K222586 — Mural Clinical Viewer (December 21, 2022)
  • K221904 — EK12 V2 Algorithm (December 20, 2022)
  • K221321 — MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System (October 18, 2022)

Other clearances for product code MWI

  • K250135 — WAVE Clinical Platform (2.0.000) (January 16, 2026)
  • K241766 — QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (August 27, 2025)
  • K242737 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (June 6, 2025)
  • K241958 — WARD-CSS (v1.2.x) (February 14, 2025)
  • K243146 — iCare APP (February 3, 2025)
  • K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (December 20, 2024)
  • K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (December 10, 2024)
  • K233446 — AMC Health CareConsole (September 27, 2024)
  • K240236 — Happy Ring Health Monitoring System (September 24, 2024)
  • K233354 — WVSM Pro (Series) (500-0030-XX) (June 26, 2024)