# K062976: Modification to Cic Pro Clinical Information Center

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Mar 16, 2007 after 168 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001112 (2000). 3 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053356: Modification to: Cic Pro Clinical Information Center Central Station, Ge Medical Systems Information Technologies (2006) Summary page 1.

## Most influential descendants
- K133882: Carescape Central Station (Formally Known as Cic Pro) (2014), 9 descendants of its own
- K162012: CARESCAPE Central Station V2 (2016), 7 descendants of its own
- K201941: Monitor B125, Monitor B105 (2020), 3 descendants of its own
- K213490: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P (2022), 2 descendants of its own
- K173107: Vios Central Station Monitor Software, Vios Central Server Software (2018), 2 descendants of its own

## Recalls of this device
- Nov 12, 2019 · Class II · Z-0726-2020: When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) v
- Mar 10, 2009 · Not classified · Z-1600-2009: GE Healthcare has become aware of a potential issue associated with the failure to restart CARESCAPE CIC Pro v5.1 on the MP100 hardware. This issue may impact patient safety.
- Feb 27, 2009 · Not classified · Z-1232-2009: GE Healthcare is aware of potential network time issues associated with the time change aspects of certain CARESCAPE CIC Pro" software versions. These issues may impact patient safety. No reported pat
- Nov 8, 2007 · Not classified · Z-0519-2008: Potential for Loss of Audible Alarming and ECG Tab Setting Changes; from Clinical Informaiton Center (CIC) Pro v5.0.3 & 5.0.6 when used in combination with Telemetry and bedside monitors.

## Indications for use
The CIC Pro Clinical Information Center central station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information Center central station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed. The CIC Pro Clinical Information Center central station supports the ability to access information from the CIC Pro Clinical Information Center central stations' products in a web browser format. Additionally, the CIC Pro Clinical Information Center central station supports the ability to access patient information collected from the unity network and stored on a network server.

Source page: https://510kreport.com/device/K062976
Methodology: https://510kreport.com/methodology