510(k) · Cleared
ClearedCT Colonography II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems · LLZ System, Image Processing, Radiological
Cleared on May 27, 2004 as substantially equivalent to K023943 (Ge Medical Systems, Inc., 2003) after a 15-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- May 27, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954355 (1995). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 2 generations backK012313 CT Colonography/NAVIGATOR2Ge Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK023943 CT ColonographyGe Medical Systems, Inc. · 2003
- This deviceK041270 CT Colonography IIGeneral Electric Medical Systems · 2004
- Descendant · cites it directly · 0 of its ownK090220 Colon View, Model CSCV-001AToshibamedical Systems Corporation · 2009
- Descendant · cites it directly · 0 of its ownK061372 Centricity AW Suite OptionGe Healthcare Information Technologies · 2006 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −2 | K012313 | CT Colonography/NAVIGATOR2 | Ge Medical Systems, Inc. | 2001 | 1 |
| −1 | K023943 | CT Colonography | Ge Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K041270 | CT Colonography II | General Electric Medical Systems | 2004 | — |
| +1 | K090220 | Colon View, Model CSCV-001A | Toshibamedical Systems Corporation | 2009 | — |
| +1 | K061372 | Centricity AW Suite Option | Ge Healthcare Information Technologies | 2006 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 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 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 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K023943 | CT ColonographySummary page 1…isted below: Model: CT Colonography Manufacturer: General Electric Medical Systems, Buc, France 5 10(k) #: K023943 Device Description: CT Colonography HI is a CT image analysis software package which allows the visualization of 2D and 3D med… | 2003 |
What descends from it? (2)
2 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)
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 9 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K090220 (Toshibamedical Systems Corporation, 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023943.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
CT Colonography II is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D, 3D and 360 dissection views, and an object oriented endoluminal display.…
Read the full statement (113 words)
CT Colonography II is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D, 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print and distribute colon image studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041270: CT Colonography II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041270
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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