Mural Clinical Viewer
FDA 510(k) K222586 · Ge Medical Systems Information Technologies, Inc.
510(k) numberK222586
Submission
- Device name
- Mural Clinical Viewer
- Applicant
- Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI, US - Received
- August 26, 2022
- Decision date
- December 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code MHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…MHX · Traditional | GE Healthcare Finland Oy | 09/01/2026SE |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional | GE Healthcare Finland Oy | 08/28/2026SE |
| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | Draeger Medical Systems, Inc. | 08/20/2026SE |
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | Edan Instruments, Inc. | 08/06/2026SE |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | Ge Medical Systems Information Technologies, Inc. | 07/24/2026SE |
| K254209 | Radius VSM and AccessoriesMHX · Traditional | Masimo Corporation | 06/04/2026SE |
| K252840 | M12 Telemetry SystemMHX · Traditional | Global Instrumentation, LLC | 05/29/2026SE |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/20/2026SE |
| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/16/2026SE |
More from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | 07/24/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | 01/26/2026SE |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | 07/09/2025SE |
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client…DQK · Special | 12/12/2024SE |
| K233810 | Portrait VSMMWI · Traditional | 04/25/2024SE |
| K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application…MWI · Traditional | 03/20/2024SE |
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK · Traditional | 12/13/2023SE |
| K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services…MWI · Traditional | 08/11/2023SE |
| K230145 | One-CufDXQ · Traditional | 03/14/2023SE |
| K221904 | EK12 V2 AlgorithmMHX · Traditional | 12/20/2022SE |
Questions and answers
When was Mural Clinical Viewer cleared by the FDA?
Mural Clinical Viewer (K222586) received a 510(k) decision of Substantially Equivalent on December 21, 2022, 117 days after the submission was received.
What is the product code of K222586?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.