510(k) · Cleared
ClearedSyngo.CT Colonography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · NWE Colon Computed Tomography System, Computer Aided Detection
Cleared on Dec 3, 2014 as substantially equivalent to K042605 (Siemens AG Medical Solutions, 2004) after a 237-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Dec 3, 2014
- Review
- 237 days
- Class
- Class II
- Product code
- NWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954355 (1995). 8 ancestors in all, the oldest K923524 (1994). No later device cites it as a predicate yet.
- 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 backK042605 Colongraphy Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2004
- This deviceK140920 Syngo.CT ColonographySiemens Medical Solutions USA, Inc. · 2014
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 | K042605 | Colongraphy Software Package with Extended Functionality | Siemens AG Medical Solutions | 2004 | — |
| 0 (this device) | K140920 | Syngo.CT Colonography | Siemens Medical Solutions USA, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 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 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? (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 |
|---|---|---|---|
| * | K042605 | Colongraphy Software Package with Extended FunctionalitySummary page 5…ices Trade Name: syngo Colonography – Software Package with Extended Functionality 510(k): K042605 Clearance Date: October 08, 2004 Classification Name: Colon Computed Tomography System,… | 2004 |
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 19 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K042605.
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. 2014, 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?
syngo.CT Colonography is used for easy-to-perform and efficient inspection of the colonic surface. It facilitates the search and diagnosis of colon lesions. The workflow management ensures that the required data and tools are offered to you according to your role and task. syngo.CT Colonography is a clinical post-processing workflow for basic virtual colonoscopy. It is designed to support the following image reconstruction techniques: • Multiplanar…
Read the full statement (182 words)
syngo.CT Colonography is used for easy-to-perform and efficient inspection of the colonic surface. It facilitates the search and diagnosis of colon lesions. The workflow management ensures that the required data and tools are offered to you according to your role and task.
syngo.CT Colonography is a clinical post-processing workflow for basic virtual colonoscopy. It is designed to support the following image reconstruction techniques:
• Multiplanar Reconstruction (MPR)
• Volume Rendering Technique (VRT)
• Perspective surface shaded display (pSSD)
The following evaluation tools are provided with this workflow:
• Virtual Flight
• Panoramic View
• Polyp Lens
• Stool Tagging • Stool Subtraction
• Polyp Enhanced Viewing (PEV)
• Movie
syngo.CT Colonography supports reporting with appropriate reporting tools such as lesion location, lesion characterization, and key image creation. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician on confirming the presence or absence of physician identified colon lesions (for example, polyps) in addition to evaluation, documentation, and follow-up of any such lesions using standard or low-dose spiral CT scanning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140920: Syngo.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/K140920
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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