510(k) · Cleared
ClearedSyngo Colonography Software Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 8, 2003 as substantially equivalent to K012313 (Ge Medical Systems, Inc., 2001) and 4 other predicates after an 11-day review. Its family tree reaches back 2 generations to 1995. 1 of the 234 devices in its family, counting itself, has a Class I recall. 227 later devices descend from it.
- Decided
- Apr 8, 2003
- Review
- 11 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K954355 (1995). 6 ancestors in all, the oldest K923524 (1994). 227 later devices descend from it, 5 citing it directly. 1 of the 234 devices in this family, counting this one, has a Class I recall.
- 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 deviceK030982 Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc. · 2003
- Descendant · cites it directly · 210 of its ownK033102 Medic Colon Model, Release 1Medicsight · 2003
- Descendant · 2 generations on · 209 of its ownK042674 Colon Car 1.2Medicsight · 2004
- Descendant · 3 generations on · 134 of its ownK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- Descendant · 4 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · cites it directly · 76 of its ownK042605 Colongraphy Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2004
Showing 5 of 227 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 227 · See all- K033102Medic Colon Model, Release 1Medicsight · 2003 · cites it directly210descendants
- K042674Colon Car 1.2Medicsight · 2004 · 2 generations on209descendants
- K061214Aquariusaps ServerTerarecon,Inc. · 2006 · 3 generations on134descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 4 generations on99descendants
- K042605Colongraphy Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2004 · cites it directly76descendants
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) | K030982 | Syngo Colonography Software Package | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +1 | K033102 | Medic Colon Model, Release 1 | Medicsight | 2003 | — |
| +2 | K042674 | Colon Car 1.2 | Medicsight | 2004 | — |
| +3 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| +4 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +1 | K042605 | Colongraphy Software Package with Extended Functionality | Siemens AG Medical Solutions | 2004 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 13 | 0 |
| 2018 | 19 | 0 |
| 2019 | 20 | 0 |
| 2020 | 20 | 0 |
| 2021 | 17 | 0 |
| 2022 | 20 | 0 |
| 2023 | 21 | 0 |
| 2024 | 22 | 0 |
| 2025 | 22 | 1 |
| 2026 | 21 | 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.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
| * | K971717 | Fly ThroughSummary page 2…DJavigator 2 KO 123 13 08/07/0 1 Workstation Siemens Fly Through K971717 09/03/97 Siemens RealTime 3D Diagnostic K9730 10 11/… | 1997 |
| * | K973010 | Realtime 3D Diagnostic WorkstationSummary page 2…Siemens Fly Through K971717 09/03/97 Siemens RealTime 3D Diagnostic K9730 10 11/10/97 Workstation (3D Virtuoso) The Syngo Colonography software package described in this 510(k… | 1997 |
| * | K923524 | Volumetric Rendering Technique OptionSummary page 2…the image processing, display and evaluation components of syngo Colonography are currently available on software options like the Volume Rendering Technique option, K923524B2, cleared on May 17'h 1994 and workstations like the syngo Multimodality Workstation, KO 10938 cleared on 26'h June 200 1 wher… | 1994 |
| * | K010938 | Syngo Multimodality Workstation | 2001 |
What descends from it? (227)
See all 2275 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 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K033102 (Medicsight, 2003) has gone furthest, with 210 descendants of its own.
- 2 other devices also cite its predicate K012313.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
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 optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of…
Read the full statement (178 words)
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 optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT or MR scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.
Due to all these capabilities the syngo Colonography software has the advantage of non-invasive evaluation of colonic lesions as compared to conventional colonoscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030982: Syngo Colonography Software Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030982
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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