510(k) Report

510(k) · Cleared

Cleared

Imagechecker-CT Workstation

K023003510(k) TraditionalCleared Nov 20, 200272-day reviewClass II21 CFR 892.2050

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

R2 Technology, Inc. · LLZ System, Image Processing, Radiological

Cleared on Nov 20, 2002 as substantially equivalent to K011142 (Terarecon,Inc., 2001) and 2 other predicates after a 72-day review. Its family tree reaches back 3 generations to 1991. 177 later devices descend from it.

Decided
Nov 20, 2002
Review
72 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K913770 (1991). 6 ancestors in all. 177 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1997: 1 other ancestor1994: 1 other ancestor2004: 6 descendants cleared2003: 2 descendants cleared2005: 3 descendants cleared2021: 8 descendants cleared2006: 5 descendants cleared2007: 7 descendants cleared2015: 8 descendants cleared2014: 8 descendants cleared2012: 13 descendants cleared2011: 2 descendants cleared2022: 10 descendants cleared2016: 6 descendants cleared2008: 5 descendants cleared2010: 1 descendant cleared2024: 16 descendants cleared2017: 8 descendants cleared2009: 7 descendants cleared2020: 6 descendants cleared2025: 19 descendants cleared2013: 3 descendants cleared2023: 9 descendants cleared2018: 10 descendants cleared2019: 4 descendants cleared2026: 11 descendants clearedK913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991K960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K020483 · Advantage Workstation 4.1 · GE Medical Systems · 2002 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 11 descendants3 generations forward: 13 descendants4 generations forward: 21 descendants5 generations forward: 26 descendants6 generations forward: 28 descendants7 generations forward: 27 descendants8 generations forward: 18 descendants9 generations forward: 14 descendants10 generations forward: 6 descendants11 generations forward: 2 descendants12 generations forward: 2 descendants13 generations forward: 2 descendants K020483 · Advantage Workstation 4.1 · GE Medical Systems · 2002 · recalledK960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 19910+5+10
  1. Root · 3 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 2 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
  3. 1 generation backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
  4. This deviceK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
  5. Descendant · cites it directly · 170 of its ownK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
  6. Descendant · 2 generations on · 164 of its ownK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
  7. Descendant · cites it directly · 143 of its ownK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
  8. Descendant · 2 generations on · 117 of its ownK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
  9. Descendant · 3 generations on · 111 of its ownK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled

Showing 5 of 177 descendants. See all descendants

Descendants cleared per year

2003: 22004: 62005: 32006: 52007: 72008: 52009: 72010: 12011: 22012: 132013: 32014: 82015: 82016: 62017: 82018: 102019: 42020: 62021: 82022: 102023: 92024: 162025: 192026: 11
2003high 19 (2025) · low 1 (2010)2026

Most influential descendants

Showing 5 of 177 · See all
  • K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · cites it directly170descendants
  • K040305VITREA2 Version 3.5Vital Images, Inc. · 2004 · 2 generations on164descendants
  • K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · cites it directly143descendants
  • K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · 2 generations on117descendants
  • K061624Vitrea, Version 3.9Vital Images, Inc. · 2006 · 3 generations on111descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K913770Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co.1991—
−2K960613GE Advantage Windows Review WorkstationGE Medical Systems1996—
−1K020483Advantage Workstation 4.1GE Medical Systems20022
0 (this device)K023003Imagechecker-CT WorkstationR2 Technology, Inc.2002—
+1K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.20032
+2K040305VITREA2 Version 3.5Vital Images, Inc.2004—
+1K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041
+2K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20052
+3K061624Vitrea, Version 3.9Vital Images, Inc.20061

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199710
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200460
200530
200650
200770
200850
200970
201010
201120
2012130
201330
201480
201580
201660
201780
2018100
201940
202060
202180
2022100
202390
2024160
2025190
2026110
FIG. 1 — Lineage of K023003, 1991–2026Source: 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), 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 LLZ? 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 LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K011142Aquarius WorkstationTerarecon,Inc.2001—
*K973010Realtime 3D Diagnostic Workstation
Summary page 1
…, Aquarius Workstation (KO11142) Siemens Realtime 3 0 Diagnostic Workstation (K973010) GE Advantage Workstation 4.1 (K020483) Device Description: The Imagechec…
Siemens Medical Solutions USA, Inc.1997—
*K020483Advantage Workstation 4.1
Summary page 1
…s Realtime 3 0 Diagnostic Workstation (K973010) GE Advantage Workstation 4.1 (K020483) Device Description: The Imagechecker-CT System is a combination of dedicated computer software and hardware. The S…
GE Medical Systems20022

Also cleared against K011142: 7 other devices →

What descends from it? (177)

See all 177

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.2003170
K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.2004143
K040028CA-1500R2 Technology, Inc.20044
K041380Imagechecker-CT Software Package with Filling Defect IndicatorR2 Technology, Inc.20043
K031248Consultiva Report Station, Model RS-1Miramedica, Inc.20031
K201501VeolityMeVis Medical Solutions AG20210
K050667R2 Family of Image Display Units with R2 Uniform Display SoftwareR2 Technology, Inc.20050

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?

  • The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K032748 (Vital Images, Inc., 2003) has gone furthest, with 170 descendants of its own.
  • 7 other devices also cite its predicate K011142.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

The general indications for use of the Imagechecker-CT Workstation are as a general imaging workstation to assist radiologists in reviewing digital computed Tomography (CT) images of the chest.

Specific indications for use for the Imagechecker-CT Workstation are the display of a composite view of 2D cross-sections, and 3D volumes of chest CT’ images, including findings or regions of interest (“ROI”) identified by the radiologist or Computer Assisted Detection (“CAD”) findings.

Indications for use as stated in the FDA summary.

Also cleared against K011142

7 other devices cite the same predicate.

  • K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc. · 2013
  • K121916IntuitionTerarecon,Inc. · 20131 recall
  • K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp. · 2012
  • K103720Synapse 3D Lung and Abdomen AnalysisFujifilm Medical Systems U.S.A, Inc. · 2011
  • K083691BonevueMicromri, Inc. · 2009
  • K082269Visage Pacs, Version 6.0/CS 3.1Visage Imaging, Inc. · 2008

More from R2 Technology, Inc.

5 FDA decisions under this applicant name. See the company

  • K051743R2 Breast Imaging WorkstationR2 Technology, Inc. · 2005
  • K050667R2 Family of Image Display Units with R2 Uniform Display SoftwareR2 Technology, Inc. · 2005
  • K041380Imagechecker-CT Software Package with Filling Defect IndicatorR2 Technology, Inc. · 2004
  • K040028CA-1500R2 Technology, Inc. · 2004

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K023003 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023003: Imagechecker-CT Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023003

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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