510(k) · Cleared
ClearedTruPlan Computed Tomography (CT) Imaging Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circle Cardiovascular Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 18, 2023 as substantially equivalent to K202212 (Circle Cardiovascular Imaging, Inc., 2021) and 1 other predicate after a 145-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- Jan 18, 2023
- Review
- 145 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K954678 (1996). 20 ancestors in all, the oldest K954668 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 6 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 5 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 4 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 3 generations backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- 2 generations backK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
- 1 generation backK202212 TruPlanCircle Cardiovascular Imaging, Inc. · 2021
- This deviceK222593 TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK260300 WatchMate SoftwareAnumana, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK242166 TribusConnectTribusmed Beheer BV · 2025
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 |
|---|---|---|---|---|---|
| −8 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −7 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −6 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −5 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −4 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −3 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| −2 | K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016 | 1 |
| −1 | K202212 | TruPlan | Circle Cardiovascular Imaging, Inc. | 2021 | — |
| 0 (this device) | K222593 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Imaging, Inc. | 2023 | — |
| +1 | K260300 | WatchMate Software | Anumana, Inc. | 2026 | — |
| +1 | K242166 | TribusConnect | Tribusmed Beheer BV | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 LLZ? 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? (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 |
|---|---|---|---|
| * | K202212 | TruPlanSummary page 4…Number: 21 CFR 892.2050 III. PREDICATE DEVICES The primary predicate is the previously cleared version of TruPlan, manufactured by Circle CVI and cleared under K202212. 3mensio Workstation, manufactured by Pie Medical Imaging and cleared under K153736, is used as a secondary predicate. The predi… | 2021 |
| * | K153736 | 3mensio WorkstationSummary page 4…e previously cleared version of TruPlan, manufactured by Circle CVI and cleared under K202212. 3mensio Workstation, manufactured by Pie Medical Imaging and cleared under K153736, is used as a secondary predicate. The predicate devices have not been subject to a design-related recall. Circle Cardiovasc… | 2016 |
What descends from it? (2)
2 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 27 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 20 ancestors have a recall of any class.
- Of its descendants, K260300 (Anumana, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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?
TruPlan enables visualization and measurement of structures of the heart and vessels for:
• Pre-procedural planning and sizing for the left atrial appendage closure (LAAC) procedure
• Post-procedural evaluation for the LAAC procedure
To facilitate the above, TruPlan provides general functionality such as:
• Segmentation of cardiovascular structures
• Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR
• Simulation of TEE views, ICE views, and fluoroscopic rendering
• Measurement and annotation tools
• Reporting tools
TruPlan’s intended patient population is comprised of adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222593 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222593: TruPlan Computed Tomography (CT) Imaging Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222593
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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