510(k) · Cleared
ClearedSim&Size
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sim&Cure · PZO Software For Visualization Of Vascular Anatomy And Intravascular Devices
Cleared on Sep 17, 2019 as substantially equivalent to K171534 (Endo Vantage, LLC, 2017) after a 250-day review. Its family tree reaches back 9 generations to 1996. 8 later devices descend from it.
- Decided
- Sep 17, 2019
- Review
- 250 days
- Class
- Class II
- Product code
- PZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K954678 (1996). 10 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations between
- 3 generations backK141475 EndosizeTherenva Sas · 2014
- 2 generations backK160376 EndoSizeTherenva Sas · 2016
- 1 generation backK171534 SurgicalPreviewEndo Vantage, LLC · 2017
- This deviceK190049 Sim&SizeSim&Cure · 2019
- Descendant · cites it directly · 5 of its ownK202322 Sim&SizeSim&Cure · 2020
- Descendant · 2 generations on · 3 of its ownK212373 Sim&SizeSim&Cure · 2022
- Descendant · 3 generations on · 2 of its ownK222664 Sim&SizeSim&Cure · 2023
- Descendant · 4 generations on · 1 of its ownK242124 Sim&SizeSim&Cure · 2024
- Descendant · cites it directly · 1 of its ownK230006 AnkyrasMentice Spain S.L. · 2023
Show all 9 generations
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 7 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 6 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 5 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 4 generations backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- 3 generations backK141475 EndosizeTherenva Sas · 2014
- 2 generations backK160376 EndoSizeTherenva Sas · 2016
- 1 generation backK171534 SurgicalPreviewEndo Vantage, LLC · 2017
- This deviceK190049 Sim&SizeSim&Cure · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K202322Sim&SizeSim&Cure · 2020 · cites it directly5descendants
- K212373Sim&SizeSim&Cure · 2022 · 2 generations on3descendants
- K222664Sim&SizeSim&Cure · 2023 · 3 generations on2descendants
- K242124Sim&SizeSim&Cure · 2024 · 4 generations on1descendant
- K230006AnkyrasMentice Spain S.L. · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −8 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −7 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −6 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −5 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −4 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| −3 | K141475 | Endosize | Therenva Sas | 2014 | — |
| −2 | K160376 | EndoSize | Therenva Sas | 2016 | — |
| −1 | K171534 | SurgicalPreview | Endo Vantage, LLC | 2017 | — |
| 0 (this device) | K190049 | Sim&Size | Sim&Cure | 2019 | — |
| +1 | K202322 | Sim&Size | Sim&Cure | 2020 | — |
| +2 | K212373 | Sim&Size | Sim&Cure | 2022 | — |
| +3 | K222664 | Sim&Size | Sim&Cure | 2023 | — |
| +4 | K242124 | Sim&Size | Sim&Cure | 2024 | — |
| +1 | K230006 | Ankyras | Mentice Spain S.L. | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 PZO? 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 PZO device
- #1 K242124 Sim&Sizescore 15.1 · 13 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 |
|---|---|---|---|
| * | K171534 | SurgicalPreviewSummary page 4…Software Regulation Number: 892.2050 Regulation Name: Picture Archiving and Communications Systems Class: II Product Code: PZO 3. Predicate Device K171534 – SurgicalPreview, EndoVantage LLC 4. Device Description Sim&Size is software that allows for the preoperational planning of me… | 2017 |
What descends from it? (8)
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 23 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K202322 (Sim&Cure, 2020) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K171534.
How does its category compare?
All PZO devicesPZO Software For Visualization Of Vascular Anatomy And Intravascular Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PZO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PZO
Too few PZO 510(k)s in any year since 2007 to give a median.
Recalls per year · PZO
No recall names PZO since 2007.
Adverse event reports per year · PZO
No MAUDE report names PZO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Simé&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement and deployment of neurointerventional devices. General functionalities are provided such as: » Segmentation of neurovascular structures * Automatic centerline detection * Visualization of X-ray based images for 2D review and 3D…
Read the full statement (100 words)
Simé&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement and deployment of neurointerventional devices.
General functionalities are provided such as:
» Segmentation of neurovascular structures
* Automatic centerline detection
* Visualization of X-ray based images for 2D review and 3D reconstruction
* Placing and sizing tools
*» Reporting tools
Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider’s judgment and analysis of the patient’s condition.
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/K190049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190049: Sim&Size.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190049
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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