510(k) · Cleared
ClearedColongraphy Software Package with Extended Functionality
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG Medical Solutions · NWE Colon Computed Tomography System, Computer Aided Detection
Cleared on Oct 8, 2004 as substantially equivalent to K030982 (Siemens Medical Solutions USA, Inc., 2003) after a 14-day review. Its family tree reaches back 3 generations to 1995. 76 later devices descend from it.
- Decided
- Oct 8, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- NWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954355 (1995). 7 ancestors in all, the oldest K923524 (1994). 76 later devices descend from it, 4 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 backK030982 Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc. · 2003
- This deviceK042605 Colongraphy Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2004
- 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
- Descendant · 4 generations on · 58 of its ownK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 4 generations on · 50 of its ownK171048 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- 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
- K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 4 generations on58descendants
- K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 4 generations on50descendants
View 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 | K030982 | Syngo Colonography Software Package | Siemens Medical Solutions USA, Inc. | 2003 | — |
| 0 (this device) | K042605 | Colongraphy Software Package with Extended Functionality | Siemens AG Medical Solutions | 2004 | — |
| +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 | — |
| +4 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +4 | K171048 | RS80A 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 11 | 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? (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 |
|---|---|---|---|
| * | K030982 | Syngo Colonography Software PackageSummary page 2…50([K) Clearance date 1. Siemens syngo Colonography Software Package K030982 April 08, 2003 In summary, Siemens is of the opinion that syngo Colonography Software Package with Ext… | 2003 |
What descends from it? (76)
See all 764 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 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K083423 (Medicsight Plc, 2011) has gone furthest, with 70 descendants of its own.
- 4 other devices also cite its predicate K030982.
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?
syngo Colonography is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified colon lesions (e.g. polyps) in addition to evaluation, documentation, and follow-up of any such lesions using standard or low-dose spiral CT or MR scanning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042605 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042605: Colongraphy Software Package with Extended Functionality.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042605
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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