510(k) · Cleared
ClearedColoncad Api 3.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicsight Plc · NWE Colon Computed Tomography System, Computer Aided Detection
Cleared on May 17, 2011 as substantially equivalent to K042674 (Medicsight, 2004) and 1 other predicate after a 909-day review. Its family tree reaches back 5 generations to 1995. 70 later devices descend from it.
- Decided
- May 17, 2011
- Review
- 909 days
- Class
- Class II
- Product code
- NWE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954355 (1995). 11 ancestors in all, the oldest K923524 (1994). 70 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 4 generations backK012313 CT Colonography/NAVIGATOR2Ge Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK030982 Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc. · 2003
- 2 generations backK033102 Medic Colon Model, Release 1Medicsight · 2003
- 1 generation backK042674 Colon Car 1.2Medicsight · 2004
- This deviceK083423 Coloncad Api 3.1Medicsight Plc · 2011
- Descendant · cites it directly · 69 of its ownK122536 Amcad-UT Detection Model 2.0Lin & Associates, LLC · 2013
- Descendant · 2 generations on · 64 of its ownK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- Descendant · 3 generations on · 58 of its ownK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 3 generations on · 50 of its ownK171048 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 3 generations on · 42 of its ownK171070 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC · 2013 · cites it directly69descendants
- K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · 2 generations on64descendants
- K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 3 generations on58descendants
- K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 3 generations on50descendants
- K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 3 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −4 | K012313 | CT Colonography/NAVIGATOR2 | Ge Medical Systems, Inc. | 2001 | 1 |
| −3 | K030982 | Syngo Colonography Software Package | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −2 | K033102 | Medic Colon Model, Release 1 | Medicsight | 2003 | — |
| −1 | K042674 | Colon Car 1.2 | Medicsight | 2004 | — |
| 0 (this device) | K083423 | Coloncad Api 3.1 | Medicsight Plc | 2011 | — |
| +1 | K122536 | Amcad-UT Detection Model 2.0 | Lin & Associates, LLC | 2013 | — |
| +2 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| +3 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +3 | K171048 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +3 | K171070 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 10 | 0 |
| 2019 | 10 | 0 |
| 2020 | 6 | 0 |
| 2021 | 9 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 NWE? 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? (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 |
|---|---|---|---|
| * | K042674 | Colon Car 1.2Summary page 3…ich is used to assist the radiologist in the detection of colorectal polyps. ColonCAD API is a modified version of its predicate Colon CAR Release 1.2, Medicsight PLC (K042674). The primary difference is the method of deployment. ColonCAD API is designed as an Application Programming Interface (A… | 2004 |
| * | K042605 | Colongraphy Software Package with Extended FunctionalitySummary page 2…edicate devices are: * Colon CAR 1.2, Mediesight PLC (K(042674) " syngo Colonography package wit extended functionality, Siemens Medical Solutions, Inc. (K042605). 5.4 Device Description Medicsight ColonCAD API is a medical imaging software tool designed to assist radiologists in the det… | 2004 |
What descends from it? (70)
See all 701 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122536 | Amcad-UT Detection Model 2.0 | 2013 | 69 |
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 16 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K122536 (Lin & Associates, LLC, 2013) has gone furthest, with 69 descendants of its own.
- 2 other devices also cite its predicate K042674.
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. 2011, this device’s year, is highlighted.
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?
Medicsight ColonCAD™ API is a non-invasive computer aided detection (CAD) image analysis software tool designed to assist radiologists in the detection of colorectal polyps during their review of digital images derived from CT colonography (CTC). This CAD software post-processes the CTC image data obtained from multi-detector computed tomography (MDCT) scanners. The device is intended to be used on patients referred for a CT Colonography examination, as…
Read the full statement (106 words)
Medicsight ColonCAD™ API is a non-invasive computer aided detection (CAD) image analysis software tool designed to assist radiologists in the detection of colorectal polyps during their review of digital images derived from CT colonography (CTC). This CAD software post-processes the CTC image data obtained from multi-detector computed tomography (MDCT) scanners.
The device is intended to be used on patients referred for a CT Colonography examination, as an overlay tool to prompt the radiologist to colonic findings that have been identified by the device. The CAD can assist radiologists after they have made an initial review of all the CTC image data, supporting their evaluation ("second read").
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083423 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083423: Coloncad Api 3.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083423
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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