510(k) · Cleared
Cleared3MENSIO 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 Apr 17, 2012 as substantially equivalent to K072653 (3Mensio Medical Imaging BV, 2008) after a 71-day review. Its family tree reaches back 5 generations to 1996. 49 later devices descend from it.
- Decided
- Apr 17, 2012
- Review
- 71 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954678 (1996). 6 ancestors in all. 49 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 4 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 3 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 2 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 1 generation backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- This deviceK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- Descendant · cites it directly · 19 of its ownK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
- Descendant · cites it directly · 16 of its ownK141475 EndosizeTherenva Sas · 2014
- Descendant · 2 generations on · 13 of its ownK160376 EndoSizeTherenva Sas · 2016
- Descendant · 3 generations on · 10 of its ownK171534 SurgicalPreviewEndo Vantage, LLC · 2017
- Descendant · 4 generations on · 8 of its ownK190049 Sim&SizeSim&Cure · 2019
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K1537363mensio WorkstationPie Medical Imaging BV · 2016 · cites it directly19descendants
- K141475EndosizeTherenva Sas · 2014 · cites it directly16descendants
- K160376EndoSizeTherenva Sas · 2016 · 2 generations on13descendants
- K171534SurgicalPreviewEndo Vantage, LLC · 2017 · 3 generations on10descendants
- K190049Sim&SizeSim&Cure · 2019 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −4 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −3 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −2 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −1 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| 0 (this device) | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| +1 | K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016 | 1 |
| +1 | K141475 | Endosize | Therenva Sas | 2014 | — |
| +2 | K160376 | EndoSize | Therenva Sas | 2016 | — |
| +3 | K171534 | SurgicalPreview | Endo Vantage, LLC | 2017 | — |
| +4 | K190049 | Sim&Size | Sim&Cure | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 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? (1)
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 |
|---|---|---|---|
| * | K072653 | 3VISEON/SurgerySummary page 1…Class 11 (21 CFR, part 892.2050, LLZ) Classification Name Picture Archiving and Communications System Predicate Devices 3visionlsurgery, cleared under K072653 Device Description 3mensio Workstation is a stand-alone software application intended to rim on a… | 2008 |
What descends from it? (49)
See all 494 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 16 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K153736 (Pie Medical Imaging BV, 2016) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K072653.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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
To facilitate the above, 3mensio Workstation provides general functionality such as:
*Segmentation of cardiovascular structures
*Automatic and manual centerline detection
*Visualization and image reconstruction techniques: 20 review, Volume Rendering, MPR,
Curved MPR, Stretched CMRP, Slabbing, MIP, AlP, MinIP
* Measurement and annotation toots
*Reporting tools
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120367: 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/K120367
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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