# K061675: Vision VXC Central Station, Model 4300

- Pathway: 510(k) (Special)
- Applicant: Invivo Corporation
- Decided: Aug 2, 2006 after 49 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: 3 generations back to K925411 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982104: Escort-Link Central Station Monitor Model 20500, Medical Data Electronics (1998) Summary page 2.
- K022453: Modification to Acuity Central Monitoring System, Welch Allyn Protocol, Inc. (2002) Summary page 2.

## Indications for use
The Vision V x C series 4300 central station monitoring system is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythnmia/ST monitoring for a variable number of Escort Bedside Monitors and a: variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only. The ST algorithm has been tested for accuracy of the ST segment measurement data. The significance of the ST segment changes must be determined by a physician.

Source page: https://510kreport.com/device/K061675
Methodology: https://510kreport.com/methodology