510(k) · Cleared
Recalled · Class II · 2019Modification to: Cic Pro Clinical Information Center Central Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Apr 19, 2006 as substantially equivalent to K032370 (Ge Medical Systems Information Technologies, 2003) after a 138-day review. Its family tree reaches back 2 generations to 2000. 22 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 19, 2006
- Review
- 138 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001112 (2000). 22 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001112 GE Marquette Clinical Information Center, GE Marquette CicGeneral Electric Medical Systems Information Techn · 2000
- 1 generation backK032370 Cic Pro Clinical Information Center Central StationGe Medical Systems Information Technologies · 2003 · Recalled
- This deviceK053356 Modification to: Cic Pro Clinical Information Center Central StationGe Medical Systems Information Technologies · 2006
- Descendant · cites it directly · 10 of its ownK073372 Electrophysiology Systems Integrator (Epsi)Systemsone · 2007
- Descendant · cites it directly · 10 of its ownK062976 Modification to Cic Pro Clinical Information CenterGe Medical Systems Information Technologies · 2007 · Recalled
- Descendant · 2 generations on · 9 of its ownK133882 Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 9 of its ownK083321 Cardio-ViewCurlview Igt, LLC · 2008
- Descendant · 3 generations on · 7 of its ownK162012 CARESCAPE Central Station V2GE Healthcare · 2016 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K073372Electrophysiology Systems Integrator (Epsi)Systemsone · 2007 · cites it directly10descendants
- K062976Modification to Cic Pro Clinical Information CenterGe Medical Systems Information Technologies · 2007 · cites it directly10descendants
- K133882Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · 2 generations on9descendants
- K083321Cardio-ViewCurlview Igt, LLC · 2008 · 2 generations on9descendants
- K162012CARESCAPE Central Station V2GE Healthcare · 2016 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001112 | GE Marquette Clinical Information Center, GE Marquette Cic | General Electric Medical Systems Information Techn | 2000 | — |
| −1 | K032370 | Cic Pro Clinical Information Center Central Station | Ge Medical Systems Information Technologies | 2003 | 5 |
| 0 (this device) | K053356 | Modification to: Cic Pro Clinical Information Center Central Station | Ge Medical Systems Information Technologies | 2006 | — |
| +1 | K073372 | Electrophysiology Systems Integrator (Epsi) | Systemsone | 2007 | — |
| +1 | K062976 | Modification to Cic Pro Clinical Information Center | Ge Medical Systems Information Technologies | 2007 | 4 |
| +2 | K133882 | Carescape Central Station (Formally Known as Cic Pro) | Ge Medical Systems Information Technologies, Inc. | 2014 | 1 |
| +2 | K083321 | Cardio-View | Curlview Igt, LLC | 2008 | — |
| +3 | K162012 | CARESCAPE Central Station V2 | GE Healthcare | 2016 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXJ device
- #1 K261469 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0…score 12.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032370 | Cic Pro Clinical Information Center Central StationSummary page 1…DXJ 21 CFR 870.1025 Detector and Alarm, Arrhythmia DSI Predicate Device: K032370 Clinical Information Center (CIC) Central Station Device Description: The CIC Pro Central Station is based on a st… | 2003 |
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2019 | Class II | Z-0726-2020 | Software in the Use Environment | 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) version 1 and Central Information… |
| Feb 27, 2009 | Not classified | Z-1232-2009 | Software design | 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 patient injuries or illnesses for the use… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K073372 (Systemsone, 2007) has gone furthest, with 10 descendants of its own.
How does its category compare?
All DXJ devicesDXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXJ
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DXJ
130in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXJ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXJ
3in 2025
MAUDE reports naming product code DXJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 8 | 29 |
| 2010 | 2 | — | 1 | 148 |
| 2011 | 4 | 53 | 1 | 129 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 3 | 174 | 0 | 4 |
| 2014 | 4 | 242 | 0 | 13 |
| 2015 | 2 | — | 0 | 15 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 4 | 164 | 0 | 10 |
| 2018 | 4 | 130 | 0 | 3 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 22 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (174 words)
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'
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053356 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053356: Modification to: Cic Pro Clinical Information Center Central Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053356
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026