510(k) Report

510(k) · Cleared

Cleared

GE Marquette Clinical Information Center, GE Marquette Cic

K001112510(k) TraditionalCleared Jun 14, 200069-day reviewClass II21 CFR 870.2450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

General Electric Medical Systems Information Techn · DXJ Display, Cathode-Ray Tube, Medical

Cleared on Jun 14, 2000 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided
Jun 14, 2000
Review
69 days
Class
Class II
Product code
DXJ
Recalls
None
Predicates
0

24 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2006: 1 descendant cleared2007: 2 descendants cleared2014: 2 descendants cleared2008: 1 descendant cleared2010: 1 descendant cleared2011: 3 descendants cleared2016: 3 descendants cleared2018: 2 descendants cleared2020: 3 descendants cleared2025: 2 descendants cleared2024: 2 descendants cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK001112 GE Marquette Clinical Information Center, GE Marquette CicGeneral Electric Medical Systems Information Techn · 2000
  2. Descendant · cites it directly · 23 of its ownK032370 Cic Pro Clinical Information Center Central StationGe Medical Systems Information Technologies · 2003 · Recalled
  3. Descendant · 2 generations on · 22 of its ownK053356 Modification to: Cic Pro Clinical Information Center Central StationGe Medical Systems Information Technologies · 2006 · Recalled
  4. Descendant · 3 generations on · 10 of its ownK073372 Electrophysiology Systems Integrator (Epsi)Systemsone · 2007
  5. Descendant · 3 generations on · 10 of its ownK062976 Modification to Cic Pro Clinical Information CenterGe Medical Systems Information Technologies · 2007 · Recalled
  6. Descendant · 4 generations on · 9 of its ownK133882 Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12007: 22008: 12010: 12011: 32014: 22016: 32018: 22020: 32022: 12024: 22025: 2
2003high 3 (2011) · low 0 (2004)2026

Most influential descendants

Showing 5 of 24 · See all
  • K032370Cic Pro Clinical Information Center Central StationGe Medical Systems Information Technologies · 2003 · cites it directly23descendants
  • K053356Modification to: Cic Pro Clinical Information Center Central StationGe Medical Systems Information Technologies · 2006 · 2 generations on22descendants
  • K073372Electrophysiology Systems Integrator (Epsi)Systemsone · 2007 · 3 generations on10descendants
  • K062976Modification to Cic Pro Clinical Information CenterGe Medical Systems Information Technologies · 2007 · 3 generations on10descendants
  • K133882Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · 4 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001112GE Marquette Clinical Information Center, GE Marquette CicGeneral Electric Medical Systems Information Techn2000—
+1K032370Cic Pro Clinical Information Center Central StationGe Medical Systems Information Technologies20035
+2K053356Modification to: Cic Pro Clinical Information Center Central StationGe Medical Systems Information Technologies20062
+3K073372Electrophysiology Systems Integrator (Epsi)Systemsone2007—
+3K062976Modification to Cic Pro Clinical Information CenterGe Medical Systems Information Technologies20074
+4K133882Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc.20141

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200720
200810
201010
201130
201420
201630
201820
202030
202210
202420
202520
FIG. 1 — Lineage of K001112, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K261469 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0…score 12.7 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (24)

See all 24

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032370Cic Pro Clinical Information Center Central StationGe Medical Systems Information Technologies200323

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K032370 (Ge Medical Systems Information Technologies, 2003) has gone furthest, with 23 descendants of its own.

How does its category compare?

All DXJ devices

DXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXJ

2in 2021

2007: 12008: 12010: 22011: 42012: 12013: 32014: 42015: 22016: 12017: 42018: 42020: 12021: 22026 (partial year): 1
2007high 4 (2011) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXJ

130in 2018

2011: 53 days median2013: 174 days median2014: 242 days median2017: 164 days median2018: 130 days median
2007high 242 (2014) · low 53 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXJ

2in 2025

2008: 22009: 82010: 12011: 12022: 12025: 2
2007high 8 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXJ

3in 2025

2007: 32008: 52009: 292010: 1482011: 1292012: 212013: 42014: 132015: 152016: 72017: 102018: 32019: 292020: 222021: 62022: 22023: 172024: 152025: 3
2007high 148 (2010) · low 2 (2022)2025

MAUDE reports naming product code DXJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—03
20081—25
20090—829
20102—1148
20114531129
20121—021
2013317404
20144242013
20152—015
20161—07
20174164010
2018413003
20190—029
20201—022
20212—06
20220—12
20230—017
20240—015
20250—23
20261—0—

More from General Electric Medical Systems…

33 FDA decisions under this applicant name. See the company

  • K023380T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
  • K021470Seer Light Compact Digital Holter RecorderGeneral Electric Medical Systems Information Techn · 2002
  • K023100Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
  • K021454Unity Network IDGeneral Electric Medical Systems Information Techn · 2002
  • K020290Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 20021 recall

Recent decisions in DXJ

The DXJ category page

  • K261469Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character).Barco N.V. · 2026
  • K212003ESSENZ Patient MonitorLivanova Deutschland, GmbH · 2021
  • K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH · 2021
  • K201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd. · 2020
  • K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc. · 2018

https://510kreport.com/device/K001112 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001112: GE Marquette Clinical Information Center, GE Marquette Cic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001112

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026