510(k) · Cleared
Recalled · Class II · 20253mensio Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pie Medical Imaging BV · LLZ System, Image Processing, Radiological
Cleared on May 27, 2016 as substantially equivalent to K120367 (Pie Medical Imaging BV, 2012) and 1 other predicate after a 151-day review. Its family tree reaches back 6 generations to 1996. 19 later devices descend from it. It has been recalled once.
- Decided
- May 27, 2016
- Review
- 151 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K954678 (1996). 18 ancestors in all, the oldest K954668 (1995). 19 later devices descend from it, 11 citing it directly.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 2 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 1 generation backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- This deviceK153736 3mensio WorkstationPie Medical Imaging BV · 2016
- Descendant · cites it directly · 3 of its ownK202212 TruPlanCircle Cardiovascular Imaging, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK222593 TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK191585 iNtuition-Structural Heart ModuleTerarecon,Inc. · 2019
- Descendant · cites it directly · 2 of its ownK190874 Materialise Mimics EnlightMaterialise NV · 2019
- Descendant · 2 generations on · 1 of its ownK250337 AiORTA - PlanViTAA Medical Solutions, Inc. · 2025
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K202212TruPlanCircle Cardiovascular Imaging, Inc. · 2021 · cites it directly3descendants
- K222593TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc. · 2023 · cites it directly2descendants
- K191585iNtuition-Structural Heart ModuleTerarecon,Inc. · 2019 · cites it directly2descendants
- K190874Materialise Mimics EnlightMaterialise NV · 2019 · cites it directly2descendants
- K250337AiORTA - PlanViTAA Medical Solutions, Inc. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −2 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −1 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| 0 (this device) | K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016 | — |
| +1 | K202212 | TruPlan | Circle Cardiovascular Imaging, Inc. | 2021 | — |
| +1 | K222593 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Imaging, Inc. | 2023 | — |
| +1 | K191585 | iNtuition-Structural Heart Module | Terarecon,Inc. | 2019 | — |
| +1 | K190874 | Materialise Mimics Enlight | Materialise NV | 2019 | — |
| +2 | K250337 | AiORTA - Plan | ViTAA Medical Solutions, Inc. | 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 |
|---|---|---|
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K120367 | 3MENSIO WorkstationSummary page 4…s II Regulation number: 21 CFR 892.2050 Classification Product Code: LLZ Predicate Devices 3mensio Workstation (K120367) Philips Intellispace Cardiovascular (K153022) Device Description The 3mensio Workstation softwar… | 2012 |
| * | K153022 | Philips IntelliSpace CardiovascularSummary page 4…Classification Product Code: LLZ Predicate Devices 3mensio Workstation (K120367) Philips Intellispace Cardiovascular (K153022) Device Description The 3mensio Workstation software allows cardiologists, radiologist and clinical… | 2015 |
What descends from it? (19)
See all 1911 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202212 | TruPlan | 2021 | 3 |
| K222593 | TruPlan Computed Tomography (CT) Imaging Software | 2023 | 2 |
| K191585 | iNtuition-Structural Heart Module | 2019 | 2 |
| K190874 | Materialise Mimics Enlight | 2019 | 2 |
| K241984 | Hi-D Imaging 4TAVR | 2025 | 1 |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | 2024 | 1 |
| K253735 | AV Vascular | 2026 | 0 |
| K250330 | 3mensio Workstation | 2025 | 0 |
| K242500 | Laralab | 2025 | 0 |
| K231324 | DASI Dimensions (V1.0) | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2025 | Class II | Z-2297-2025 | Software change control | When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K202212 (Circle Cardiovascular Imaging, Inc., 2021) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K120367.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
3mensio Workstation enables visualization and measurement of structures of the heart and vessels for: * Pre-operational planning and sizing for cardiovascular interventions and surgery * Postoperative evaluation * Support of clinical diagnosis by quantifying dimensions in coronary arteries * Support of clinical diagnosis by quantifying calcifications (calcium scoring) in the coronary arteries To facilitate the above, the 3mensio Workstation provides…
Read the full statement (102 words)
3mensio Workstation enables visualization and measurement of structures of the heart and vessels for:
* Pre-operational planning and sizing for cardiovascular interventions and surgery
* Postoperative evaluation
* Support of clinical diagnosis by quantifying dimensions in coronary arteries
* Support of clinical diagnosis by quantifying calcifications (calcium scoring) in the coronary arteries
To facilitate the above, the 3mensio Workstation provides general functionality such as:
» Segmentation of cardiovascular structures
» Automatic and manual centerline detection
* Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR, Curved MPR, Stretched CMPR, Slabbing, MIP, AIP, MinIP
* Measurement and annotation tools
* Reporting tools
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153736: 3mensio Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153736
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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