510(k) Report

510(k) · Cleared

Cleared

Cadens (TM) Colon

K111758510(k) TraditionalCleared Feb 14, 2012237-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

Dog Microsystems, Inc. · LLZ System, Image Processing, Radiological

Cleared on Feb 14, 2012 as substantially equivalent to K030982 (Siemens Medical Solutions USA, Inc., 2003) and 2 other predicates after a 237-day review. Its family tree reaches back 7 generations to 1991.

Decided
Feb 14, 2012
Review
237 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K913770 (1991). 32 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2003: 1 other ancestor2002: 2 other ancestors2001: 7 other ancestors2000: 3 other ancestors1997: 2 other ancestors1995: 1 other ancestor1994: 3 other ancestors1999: 1 other ancestor1998: 2 other ancestors1996: 2 other ancestorsK913770 · 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 · recalledK023003 · Imagechecker-CT Workstation · R2 Technology, Inc. · 2002K032748 · VITREA2, Version 3.4 Medical Image Processing Software · Vital Images, Inc. · 2003 · recalledK040305 · VITREA2 Version 3.5 · Vital Images, Inc. · 2004K043333 · VITREA2, Version 3.7 Medical Image Processing System · Vital Images, Inc. · 2004 · recalled19901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 10 other ancestors3 generations back: 4 other ancestors4 generations back: 5 other ancestors5 generations back: 3 other ancestors6 generations back: 1 other ancestor K043333 · VITREA2, Version 3.7 Medical Image Processing System · Vital Images, Inc. · 2004 · recalledK040305 · VITREA2 Version 3.5 · Vital Images, Inc. · 2004K032748 · VITREA2, Version 3.4 Medical Image Processing Software · Vital Images, Inc. · 2003 · recalledK023003 · Imagechecker-CT Workstation · R2 Technology, Inc. · 2002K020483 · 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. · 1991−50
  1. Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
  3. 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
  4. 4 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
  5. 3 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
  6. 2 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
  7. 1 generation backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
  8. This deviceK111758 Cadens (TM) ColonDog Microsystems, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K913770Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co.1991—
−6K960613GE Advantage Windows Review WorkstationGE Medical Systems1996—
−5K020483Advantage Workstation 4.1GE Medical Systems20022
−4K023003Imagechecker-CT WorkstationR2 Technology, Inc.2002—
−3K032748VITREA2, 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
0 (this device)K111758Cadens (TM) ColonDog Microsystems, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199430
199510
199620
199720
199820
199910
200030
200170
200220
200310
200410
FIG. 1 — Lineage of K111758, 1991–2012Source: 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
*K030982Syngo Colonography Software Package
Summary page 1
…21 CF/I 892.2050 Class fl, PRODUCT CODE: 90-LLZ 8. PREDICATE DEVICES - Siemens Syngo Colonography software package (K030982) - VITAL Images Vitrea (K043333) - Viatronix V3D Colon, r…
Siemens Medical Solutions USA, Inc.2003—
*K043333VITREA2, Version 3.7 Medical Image Processing System
Summary page 1
…PREDICATE DEVICES - Siemens Syngo Colonography software package (K030982) - VITAL Images Vitrea (K043333) - Viatronix V3D Colon, rev 1.3 (K040126) 9. DEVICE DESCRIPTION Similar to the Siemens…
Vital Images, Inc.20041
*K040126Viatronix V3D Colon, Revision 1.3
Summary page 1
…graphy software package (K030982) - VITAL Images Vitrea (K043333) - Viatronix V3D Colon, rev 1.3 (K040126) 9. DEVICE DESCRIPTION Similar to the Siemens Syngo Colonography software package, VIATRONIX V3D Colon and VITAL Images CT…
Viatronix, Inc.2004—

Also cleared against K030982: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 21 years and passes through 5 companies; a new generation was cleared every 11 months on median.
  • 7 of the 32 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K030982.

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. 2012, this device’s year, is highlighted.

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?

CADIENS'' Colon isa self-contained image analysis software package for evaluating CT volume datasets. Combining enhanced commercially available digital image processing tools with optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-luminal view), the wall and the outside (extra-luminal view) of the colon. It provides functionality for display, measurement and electronic cleansing to…

Read the full statement (179 words)

CADIENS'' Colon isa self-contained image analysis software package for evaluating CT volume datasets. Combining enhanced commercially available digital image processing tools with optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-luminal view), the wall and the outside (extra-luminal view) of the colon. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine views. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue, with respect to their size, dimensions, shape and position.

It is to be used only by trained and instructed health care professionals.

Indications for use as stated in the FDA summary.

Also cleared against K030982

4 other devices cite the same predicate.

  • K090220Colon View, Model CSCV-001AToshibamedical Systems Corporation · 2009
  • K052963Mediq Version 1.0Clario Medical Imaging, Inc. · 2005
  • K042605Colongraphy Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2004
  • K033102Medic Colon Model, Release 1Medicsight · 2003

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/K111758 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111758: Cadens (TM) Colon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111758

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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