510(k) · Cleared
ClearedCT Colonography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on May 6, 2003 as substantially equivalent to K012313 (Ge Medical Systems, Inc., 2001) and 1 other predicate after a 161-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- May 6, 2003
- Review
- 161 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954355 (1995). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 1 generation backK012313 CT Colonography/NAVIGATOR2Ge Medical Systems, Inc. · 2001 · Recalled
- This deviceK023943 CT ColonographyGe Medical Systems, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK041270 CT Colonography IIGeneral Electric Medical Systems · 2004
- Descendant · cites it directly · 0 of its ownK090220 Colon View, Model CSCV-001AToshibamedical Systems Corporation · 2009
- Descendant · 2 generations on · 0 of its ownK061372 Centricity AW Suite OptionGe Healthcare Information Technologies · 2006 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K041270CT Colonography IIGeneral Electric Medical Systems · 2004 · cites it directly2descendants
- K090220Colon View, Model CSCV-001AToshibamedical Systems Corporation · 2009 · cites it directly0descendants
- K061372Centricity AW Suite OptionGe Healthcare Information Technologies · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −1 | K012313 | CT Colonography/NAVIGATOR2 | Ge Medical Systems, Inc. | 2001 | 1 |
| 0 (this device) | K023943 | CT Colonography | Ge Medical Systems, Inc. | 2003 | — |
| +1 | K041270 | CT Colonography II | General Electric Medical Systems | 2004 | — |
| +1 | K090220 | Colon View, Model CSCV-001A | Toshibamedical Systems Corporation | 2009 | — |
| +2 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K012313 | CT Colonography/NAVIGATOR2 | 2001 |
| * | K020658 | Viatronix V3D ColonSummary page 2…rms as well as devices currently on the market. GE considers features of the CT Colonography to be equivalent to those of Colongrapy/Navigator2 (KO 12313) and V3D-Colon (K020658). Page 2 of 2 D E P ~ T ~ O ~ ~ ~ ~ ~ H U ~ ~ ~ A N S E R ~ C E… | 2002 |
| † | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | 1991 |
| † | K923077 | Advantage Windows 3D Option and Dentascan Option | 1993 |
| † | K972399 | Advantage Windows Volume Rendering Option | 1997 |
What descends from it? (3)
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 8 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K041270 (General Electric Medical Systems, 2004) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K012313.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
CT Colonography 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 supine & prone data sets, and an object oriented endoluminal display. In comparison…
Read the full statement (110 words)
CT Colonography 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 supine & prone data sets, 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/K023943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023943: CT Colonography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023943
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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