510(k) · Cleared
ClearedIcad Veralook CTC Cad Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icad, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 4, 2010 as substantially equivalent to K042674 (Medicsight, 2004) and 1 other predicate after a 439-day review. Its family tree reaches back 5 generations to 1995. 2 later devices descend from it.
- Decided
- Aug 4, 2010
- Review
- 439 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954355 (1995). 11 ancestors in all, the oldest K923524 (1994). 2 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 deviceK091529 Icad Veralook CTC Cad SoftwareIcad, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK173744 ProFuse CADEigen · 2018
- Descendant · 2 generations on · 0 of its ownK191278 Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix) · 2019
Most influential descendants
Showing 2 of 2 · See allView 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) | K091529 | Icad Veralook CTC Cad Software | Icad, Inc. | 2010 | — |
| +1 | K173744 | ProFuse CAD | Eigen | 2018 | — |
| +2 | K191278 | Rsi-Mri+ | Multimodal Imaging Services Corporation (Dba Healthlytix) | 2019 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 JAK? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042674 | Colon Car 1.2Summary page 2…for the purpose of assisting radiologists and other clinicians in the evaluation of polyps. 510(k) Reference No. Device Name Manufacturer K042674 Colon CAR 1.2 Medicsight K042605 Syngo Colonography… | 2004 |
| * | K042605 | Colongraphy Software Package with Extended FunctionalitySummary page 2…luation of polyps. 510(k) Reference No. Device Name Manufacturer K042674 Colon CAR 1.2 Medicsight K042605 Syngo Colonography Siemens Ag, Medical Software Package With… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173744 | ProFuse CAD | 2018 | 1 |
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 15 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, K173744 (Eigen, 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K042674.
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. 2010, this device’s year, is highlighted.
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?
iCAD's VeraLookTM CTC CAD is intended to automatically detect potential polyps in CT Colonography exams. The, identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091529 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091529: Icad Veralook CTC Cad Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091529
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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