510(k) · Cleared
ClearedEndoSize
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therenva Sas · LLZ System, Image Processing, Radiological
Cleared on Apr 12, 2016 as substantially equivalent to K141475 (Therenva Sas, 2014) after a 62-day review. Its family tree reaches back 7 generations to 1996. 13 later devices descend from it.
- Decided
- Apr 12, 2016
- Review
- 62 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954678 (1996). 8 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 3 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 2 generations backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- 1 generation backK141475 EndosizeTherenva Sas · 2014
- This deviceK160376 EndoSizeTherenva Sas · 2016
- Descendant · cites it directly · 10 of its ownK171534 SurgicalPreviewEndo Vantage, LLC · 2017
- Descendant · 2 generations on · 8 of its ownK190049 Sim&SizeSim&Cure · 2019
- Descendant · 3 generations on · 5 of its ownK202322 Sim&SizeSim&Cure · 2020
- Descendant · 4 generations on · 3 of its ownK212373 Sim&SizeSim&Cure · 2022
- Descendant · 5 generations on · 2 of its ownK222664 Sim&SizeSim&Cure · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K171534SurgicalPreviewEndo Vantage, LLC · 2017 · cites it directly10descendants
- K190049Sim&SizeSim&Cure · 2019 · 2 generations on8descendants
- K202322Sim&SizeSim&Cure · 2020 · 3 generations on5descendants
- K212373Sim&SizeSim&Cure · 2022 · 4 generations on3descendants
- K222664Sim&SizeSim&Cure · 2023 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −3 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −2 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| −1 | K141475 | Endosize | Therenva Sas | 2014 | — |
| 0 (this device) | K160376 | EndoSize | Therenva Sas | 2016 | — |
| +1 | K171534 | SurgicalPreview | Endo Vantage, LLC | 2017 | — |
| +2 | K190049 | Sim&Size | Sim&Cure | 2019 | — |
| +3 | K202322 | Sim&Size | Sim&Cure | 2020 | — |
| +4 | K212373 | Sim&Size | Sim&Cure | 2022 | — |
| +5 | K222664 | Sim&Size | Sim&Cure | 2023 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K141475 | EndosizeSummary page 4…proposed software changes in the already 510(k) cleared EndoSize software (K141475) Manufacturer Name: Therenva SAS 4 rue Jean Jaurès… | 2014 |
What descends from it? (13)
See all 132 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 20 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K171534 (Endo Vantage, LLC, 2017) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K141475.
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?
EndoSize enables visualization and measurement of structures of the heart and vessels for pre-operational planning and sizing for cardiovascular interventions and surgery, and for postoperative evaluation.
General functionalities are provided such as:
Segmentation of cardiovascular structures
Automatic and manual centerline detection
Visualization of CT scan images in every planes, 2D review, 3D reconstruction, Volume Rendering, MPR, Stretched CMPR
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/K160376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160376: EndoSize.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160376
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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