Cleared Traditional

Mural Clinical Viewer

K222586 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular
Dec 2022
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K222586 is an FDA 510(k) clearance for the Mural Clinical Viewer, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on December 21, 2022, 117 days after receiving the submission on August 26, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K222586 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2022
Decision Date December 21, 2022
Days to Decision 117 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

Similar Devices — MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 418
IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
K252726 · Philips Medizin Systeme Boeblingen GmbH · Feb 2026
Corvair Monza
K252589 · AliveCor, Inc. · Jan 2026
Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
K250854 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2025
IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
K251702 · Philips Medizin Systeme B?blingen GmbH · Nov 2025
IntelliVue Patient monitors MX400, MX450, MX500, MX550
K251146 · Philips Medizin Systeme Boeblingen GmbH · Oct 2025
IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
K250453 · Philips Medizin Systeme B?blingen GmbH · Sep 2025

More from Ge Medical Systems...

View all
MAC 7 Resting ECG Analysis System
K251670 · DPS · Jan 2026
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
K242562 · MHX · Jul 2025
Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
K243540 · DQK · Dec 2024
Portrait VSM
K233810 · MWI · Apr 2024
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
K234130 · MWI · Mar 2024