510(k) · Cleared
ClearedColon Car 1.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicsight · NWE Colon Computed Tomography System, Computer Aided Detection
Cleared on Oct 19, 2004 as substantially equivalent to K033102 (Medicsight, 2003) after a 20-day review. Its family tree reaches back 4 generations to 1995. 1 of the 219 devices in its family, counting itself, has a Class I recall. 209 later devices descend from it.
- Decided
- Oct 19, 2004
- Review
- 20 days
- Class
- Class II
- Product code
- NWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954355 (1995). 9 ancestors in all, the oldest K923524 (1994). 209 later devices descend from it, 3 citing it directly. 1 of the 219 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 3 generations backK012313 CT Colonography/NAVIGATOR2Ge Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK030982 Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc. · 2003
- 1 generation backK033102 Medic Colon Model, Release 1Medicsight · 2003
- This deviceK042674 Colon Car 1.2Medicsight · 2004
- Descendant · cites it directly · 134 of its ownK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- Descendant · 2 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · cites it directly · 70 of its ownK083423 Coloncad Api 3.1Medicsight Plc · 2011
- Descendant · 2 generations on · 69 of its ownK122536 Amcad-UT Detection Model 2.0Lin & Associates, LLC · 2013
- Descendant · 3 generations on · 64 of its ownK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
Showing 5 of 209 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…6 generations on · 2025
Most influential descendants
Showing 5 of 209 · See all- K061214Aquariusaps ServerTerarecon,Inc. · 2006 · cites it directly134descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 2 generations on99descendants
- K083423Coloncad Api 3.1Medicsight Plc · 2011 · cites it directly70descendants
- K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC · 2013 · 2 generations on69descendants
- K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · 3 generations on64descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −3 | K012313 | CT Colonography/NAVIGATOR2 | Ge Medical Systems, Inc. | 2001 | 1 |
| −2 | K030982 | Syngo Colonography Software Package | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −1 | K033102 | Medic Colon Model, Release 1 | Medicsight | 2003 | — |
| 0 (this device) | K042674 | Colon Car 1.2 | Medicsight | 2004 | — |
| +1 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| +2 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +1 | K083423 | Coloncad Api 3.1 | Medicsight Plc | 2011 | — |
| +2 | K122536 | Amcad-UT Detection Model 2.0 | Lin & Associates, LLC | 2013 | — |
| +3 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 19 | 0 |
| 2019 | 20 | 0 |
| 2020 | 20 | 0 |
| 2021 | 16 | 0 |
| 2022 | 20 | 0 |
| 2023 | 20 | 0 |
| 2024 | 20 | 0 |
| 2025 | 21 | 1 |
| 2026 | 19 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K033102 | Medic Colon Model, Release 1Summary page 1…available device: Manufacturer Device 510(k) No. Clearance Date MEDICSIGHT MedicColon 1.0 K033 102 November 5"' 2003 Mcdicsight Colon CA RTM 1.2 Special 510(k) submission… | 2003 |
What descends from it? (209)
See all 2093 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K061214 (Terarecon,Inc., 2006) has gone furthest, with 134 descendants of its own.
How does its category compare?
All NWE devicesNWE Colon Computed Tomography System, Computer Aided Detection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NWE
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NWE
Too few NWE 510(k)s in any year since 2007 to give a median.
Recalls per year · NWE
No recall names NWE since 2007.
Adverse event reports per year · NWE
No MAUDE report names NWE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Colon CAR 1.2 is a PC-based. stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the colon derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of polyps, cancers and other lesions. The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool. or…
Read the full statement (125 words)
Colon CAR 1.2 is a PC-based. stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the colon derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of polyps, cancers and other lesions. The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool. or “semi-automatically” through the user selecting single or double seed points followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images.
Colon CAR 1.2 contains additional imaging tools which allow enhancement of specified features, and which the clinician can view simultaneously with the non-enhanced view.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042674 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042674: Colon Car 1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042674
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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