# K152973: Dyna-Vision Telemonitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Techmedic Development International B.V.
- Decided: Apr 29, 2016 after 204 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962603 (1997). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141167: Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and Secure Server Software Library), Vitalconnect, Inc. (2014) Summary page 4.
- K092947: Telesentry, Model TS01, Scottcare Corporation (2010) Summary page 4.
- K080255: Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter, Nonin Medical, Inc. (2008) Summary page 4.
- K070339: Disposable Temperature Probes/Sensors and Instrument Cables, Cincinnati Sub-Zero Products, Inc. (2007) Summary page 4.
- K012451: Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246, Welch Allyn Protocol, Inc. (2001) Summary page 4.

## Indications for use
The Dyna-Vision Telemonitoring System is a wireless monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings and for normal daily activities. Physiological data recorded include: Electrocardiography (EGG). Heart Rate. Heart Rate variability (R-R interval). Peripheral capillary Oxygen saturation (SpO2). Skin Temperature and respiration effort. Data is transmitted wirelessly in near real time to a central location where it is stored for analysis. The Dyna-Vision™ system can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. Data from the Dyna-Vision™ system is intended to be used by healthcare professionals as an aid to diagnosis and treatment. The device is intended for use on general care patients aged 18 years or more, as a general patient monitor, to provide physiological information. It is not intended for use on critical care patients.

Source page: https://510kreport.com/device/K152973
Methodology: https://510kreport.com/methodology