# K012349: Metavision Clinical Information System

- Pathway: 510(k) (Traditional)
- Applicant: Imdsoft, Ltd.
- Decided: Jan 29, 2002 after 189 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K941811 (1994). 15 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992636: HP Carevue 9000 Clinical Information System, Model M2331A, Hewlett-Packard Co. (1999) Summary page 1.

## Most influential descendants
- K113214: Tlink Data Management System (DMS) (2012), 3 descendants of its own
- K131816: Sorin Connect Data Management System (2013), 2 descendants of its own
- K170460: Sorin Connect (2017), 1 descendant of its own
- K212003: ESSENZ Patient Monitor (2021), 0 descendants of its own
- K143372: AWARE (2015), 0 descendants of its own

## Indications for use
The MetaVision Graphical Patient Information System is indicated for use in data collection, display, management, and storage in the intensive care unit. The system is used in conjunction with independent patient bedside devices and systems, connected via a network. The way the system is used for generating patient records, computation of drug and fluid dosage and research tasks is determined by the health care providers, in terms of their environment and requirements. The MetaVision application is resident on a workstation that provides for data input and patient data display--to health care professionals. Typically, a MetaVision system comprises several workstations connected via a network system to one or more servers. Data is stored and managed by servers. The MetaVision system network can communicate with a number of remotely located patient care units.

Source page: https://510kreport.com/device/K012349
Methodology: https://510kreport.com/methodology