# K053356: Modification to: Cic Pro Clinical Information Center Central Station

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Apr 19, 2006 after 138 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001112 (2000). 2 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032370: Cic Pro Clinical Information Center Central Station, Ge Medical Systems Information Technologies (2003) Summary page 1.

## Most influential descendants
- K073372: Electrophysiology Systems Integrator (Epsi) (2007), 10 descendants of its own
- K062976: Modification to Cic Pro Clinical Information Center (2007), 10 descendants of its own
- K133882: Carescape Central Station (Formally Known as Cic Pro) (2014), 9 descendants of its own
- K083321: Cardio-View (2008), 9 descendants of its own
- K162012: CARESCAPE Central Station V2 (2016), 7 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
- 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

## 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 trom monitors aund telenrtu-y sy'stems can be displa cd and printed from the CIG Pro Clinical Information Center Central Station. Beat to beat patienm information for all parameters and waveforms from the hedside and tlemetry ssteins caln be displayed. The CIC1iro Clinical Information CetCer CCenral Station suIpporIts ttr ability to access infornmation from ('K' Pro Clinical Information Center ( cntral Station' products in a web browser format. Additionalhl ('IC Pro Clinica. Informlation Centel ('c<ita! 1tation supporns the ability to access patient infornmation collected Irma the [ oily netork anicl stored on I nct:'ork SCI'

Source page: https://510kreport.com/device/K053356
Methodology: https://510kreport.com/methodology
