# K150082: Panorama Patient Monitoring Network

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Sep 2, 2015 after 230 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K941811 (1994). 169 ancestors in all.
No later device cites it as a predicate yet.
0 of 170 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142601: Panorama Patient Monitoring Network, Shenzhen Mindray Bio-Medical Electronics Co. (2014) Summary page 6.
- K132036: Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016), Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (2014) Summary page 6.
- K101521: ST/AR ST and Arrhythmia Software Model: Release K.O, Philips Medical Systems (2010) Summary page 6.

## Recalls of this device
- Dec 15, 2015 · Class II · Z-0701-2016: An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will be lost for about 2.5 

## Indications for use
The indications for use for the Panorama Patient Monitoring Network include: • Viewing real time patient clinical and demographic data • Graphical and numeric trending of clinical data • Storing and printing of clinical and demographic data • Setting independent alarm limits for data sent by the bedside monitor The clinical data displayed by the Panorama Patient Monitoring Network is obtained from one or more compatible physiological monitors and includes: ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, QT Analysis and heart rate(HR)), Invasive Blood Pressure (IBP), Non-Invasive Blood Pressure(NIBP), Blood Oxygenation (SpO2), Pulse Rate (PR), Respiration Rate (RESP), Respiration Gases(O2,CO2), Temperature(TEMP), Anesthetic Gases (AG), Cardiac Output(C.O.), Bispectral Index (BIS), and Hemodynamics. The Panorama Patient Monitoring Network is intended for use in a fixed location, in the healthcare facility setting, as a central viewing station. The Panorama Patient Monitoring Network is not intended to be directly connected to the patient at any time or installed in a patient’s vicinity. The Panorama Network includes the Panorama Telemetry System which acquires and monitors physiological data for ambulating patients within a defined coverage area. The system processes the physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The Panorama Telemetry System is intended for installation in a hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility. The physiological parameters monitored through telemetry include ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, QT Analysis and heart rate(HR)), blood oxygenation (SpO2), Pulse Rate (PR). Received data is calculated at the Panorama Central Station, and can be displayed, trended, stored and printed at the Panorama Central Station. The Panorama Patient Monitoring Network is intended for use under the direct supervision of a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K150082
Methodology: https://510kreport.com/methodology