# K031760: Viewpoint Telemetry System

- Pathway: 510(k) (Abbreviated)
- Applicant: Datascope Corp.
- Decided: Oct 10, 2003 after 126 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903702 (1990). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021681: Micropaq, Models 402, 404, Welch Allyn Protocol, Inc. (2002)
- K022453: Modification to Acuity Central Monitoring System, Welch Allyn Protocol, Inc. (2002)
- K020524: Patientnet Monitoring System, General Electric Medical Systems Information Techn (2002)

## Most influential descendants
- K142601: Panorama Patient Monitoring Network (2014), 1 descendant of its own
- K150082: Panorama Patient Monitoring Network (2015), 0 descendants of its own

## Recalls of this device
- Jan 8, 2014 · Class II · Z-1156-2014: Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindray¿s V-Ser
- Apr 10, 2009 · Not classified · Z-1401-2009: Software Anomaly: Software anomaly can occur when the Panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the sys
- Dec 7, 2005 · Not classified · Z-0437-06: Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.
- Aug 19, 2005 · Not classified · Z-1567-05: The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.
- Jun 16, 2005 · Not classified · Z-1104-05: Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.

## Indications for use
The Indications for use for the Viewpoint Central Monitoring System 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 Viewpoint Central Monitoring System is obtained from one or more Datascope compatible physiological monitors and includes: ECG waveforms, Invasive and Non-Invasive Blood Pressure, Blood Oxygenation (Sp02), Heart Rate, Respiration Rate, Temperature, C 0 2 inspired and end-tidal, Ventricular Arrythmia analysis and ST Segment analysis. The Viewpoint Central Monitoring System is intended for use in a fixed location, in the health care facility setting, as a central viewing station. The Viewpoint Central Monitoring System is not intended to be directly connected to the patient at any time, or installed in a patient's vicinity. The Viewpoint Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The Viewpoint Telemetry System is intended for installation in the hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility. The physiological parameters monitored include ECG, Heart Rate from ECG, Lethal and Non-Lethal Arrhythmia Detection and ST Segment Analysis. Received data is sent to the Viewpoint Server for ECG processing via Ethernet. This information can be displayed, trended, stored, and printed at the Viewpoint Central Station.

Source page: https://510kreport.com/device/K031760
Methodology: https://510kreport.com/methodology