510(k) · Cleared
Cleared3VISEON
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3Mensio Medical Imaging BV · LLZ System, Image Processing, Radiological
Cleared on Nov 19, 2004 as substantially equivalent to K992654 (Voxar Limited, 1999) after a 10-day review. Its family tree reaches back 3 generations to 1996. 52 later devices descend from it.
- Decided
- Nov 19, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954678 (1996). 52 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 2 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 1 generation backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- This deviceK043097 3VISEON3Mensio Medical Imaging BV · 2004
- Descendant · cites it directly · 51 of its ownK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- Descendant · 2 generations on · 49 of its ownK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- Descendant · 3 generations on · 19 of its ownK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
- Descendant · 3 generations on · 16 of its ownK141475 EndosizeTherenva Sas · 2014
- Descendant · 4 generations on · 13 of its ownK160376 EndoSizeTherenva Sas · 2016
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K0726533VISEON/Surgery3Mensio Medical Imaging BV · 2008 · cites it directly51descendants
- K1203673MENSIO WorkstationPie Medical Imaging BV · 2012 · 2 generations on49descendants
- K1537363mensio WorkstationPie Medical Imaging BV · 2016 · 3 generations on19descendants
- K141475EndosizeTherenva Sas · 2014 · 3 generations on16descendants
- K160376EndoSizeTherenva Sas · 2016 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −2 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −1 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| 0 (this device) | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| +1 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| +2 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| +3 | K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016 | 1 |
| +3 | K141475 | Endosize | Therenva Sas | 2014 | — |
| +4 | K160376 | EndoSize | Therenva Sas | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K992654 | Plug 'N View 3D, Version 1.0Summary page 1…Device Classification Name System, Image Processing, Radiology Regulation Number 892.2050 510(k) Number K992654 Device Name Plug" n View 3DT M Applicant Voxar Limited Product… | 1999 |
What descends from it? (52)
See all 521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072653 | 3VISEON/Surgery | 2008 | 51 |
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 8 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K072653 (3Mensio Medical Imaging BV, 2008) has gone furthest, with 51 descendants of its own.
- 15 other devices also cite its predicate K992654.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
3viseonTM is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043097: 3VISEON.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043097
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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