510(k) · Cleared
ClearedMedic Colon Model, Release 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicsight · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 5, 2003 as substantially equivalent to K012072 (Voxar Limited, 2001) and 1 other predicate after a 37-day review. Its family tree reaches back 3 generations to 1995. 1 of the 219 devices in its family, counting itself, has a Class I recall. 210 later devices descend from it.
- Decided
- Nov 5, 2003
- Review
- 37 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954355 (1995). 8 ancestors in all, the oldest K923524 (1994). 210 later devices descend from it, 1 citing it directly. 1 of the 219 devices in this family, counting this one, has a Class I recall.
- 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 deviceK033102 Medic Colon Model, Release 1Medicsight · 2003
- Descendant · cites it directly · 209 of its ownK042674 Colon Car 1.2Medicsight · 2004
- Descendant · 2 generations on · 134 of its ownK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- Descendant · 3 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 2 generations on · 70 of its ownK083423 Coloncad Api 3.1Medicsight Plc · 2011
- Descendant · 3 generations on · 69 of its ownK122536 Amcad-UT Detection Model 2.0Lin & Associates, LLC · 2013
Showing 5 of 210 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 210 · See all- K042674Colon Car 1.2Medicsight · 2004 · cites it directly209descendants
- K061214Aquariusaps ServerTerarecon,Inc. · 2006 · 2 generations on134descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 3 generations on99descendants
- K083423Coloncad Api 3.1Medicsight Plc · 2011 · 2 generations on70descendants
- K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC · 2013 · 3 generations on69descendants
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) | K033102 | Medic Colon Model, Release 1 | Medicsight | 2003 | — |
| +1 | K042674 | Colon Car 1.2 | Medicsight | 2004 | — |
| +2 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| +3 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +2 | K083423 | Coloncad Api 3.1 | Medicsight Plc | 2011 | — |
| +3 | K122536 | Amcad-UT Detection Model 2.0 | Lin & Associates, LLC | 2013 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 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.
Top candidate predicates for a new JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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.
What descends from it? (210)
See all 2101 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042674 | Colon Car 1.2 | 2004 | 209 |
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 · 7 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 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K042674 (Medicsight, 2004) has gone furthest, with 209 descendants of its own.
- 2 other devices also cite its predicate K012072.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
MedicColon I 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 a seed point followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033102 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033102: Medic Colon Model, Release 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033102
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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