510(k) · Cleared
ClearedVitrea CT Transcatheter Aortic Valve Replacment (Tavr) Planning
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Images, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 25, 2013 as substantially equivalent to K120367 (Pie Medical Imaging BV, 2012) after a 186-day review. Its family tree reaches back 6 generations to 1996. 5 later devices descend from it.
- Decided
- Feb 25, 2013
- Review
- 186 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954678 (1996). 7 ancestors in all. 5 later devices descend from it, 3 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 deviceK122578 Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) PlanningVital Images, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK151212 Ziostation2Qi Imaging, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK260324 Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK200315 Ziostation2Ziosoft, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK132524 CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems · 2014 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K151212Ziostation2Qi Imaging, LLC · 2015 · cites it directly2descendants
- K181892Ziostation2Ziosoft, Inc. · 2018 · 2 generations on1descendant
- K260324Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc. · 2026 · cites it directly0descendants
- K200315Ziostation2Ziosoft, Inc. · 2020 · 3 generations on0descendants
- K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems · 2014 · cites it directly0descendants
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) | K122578 | Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) Planning | Vital Images, Inc. | 2013 | — |
| +1 | K151212 | Ziostation2 | Qi Imaging, LLC | 2015 | — |
| +2 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | — |
| +1 | K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Canon Medical Informatics, Inc. | 2026 | — |
| +3 | K200315 | Ziostation2 | Ziosoft, Inc. | 2020 | — |
| +1 | K132524 | CT Transcatheter Aortic Valve Implantation (Tavi) Planning Application | Philips Medical Systems | 2014 | 1 |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K120367 | 3MENSIO WorkstationSummary page 1…ystem Classification Name: System, Image Processing, Radiological (21 CEFR. 892.2050, LLZ) Predicate Device: Pie Medical Imaging 8BV., 3mensio Workstation (K120367) Device Description: Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive post- processing applica… | 2012 |
| † | K071331 | Vitrea Version 4.0 | 2007 |
What descends from it? (5)
3 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 17 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K151212 (Qi Imaging, LLC, 2015) has gone furthest, with 2 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. 2013, 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?
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive post-processing application designed to assist medical professionals with the assessment of the aortic valve and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures. Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning includes general functionality such as: The software processes CT (computed…
Read the full statement (171 words)
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive post-processing application designed to assist medical professionals with the assessment of the aortic valve and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning includes general functionality such as:
The software processes CT (computed tomography) image data to provide 3D segmentation of heart structures and vessels relevant to approach planning.
The user can review the 20 and 3D images to select and plan the delivery path.
The user can determine C-arm angles for use during the procedure.
The user can verify and adjust the results of segmentation and cross-section measurements.
The software provides visualization techniques such as volume rendering, MIP, MPR and curved MPR.
The user can identify and edit contours and the centerline automatically or manually.
The user can generate a report with relevant approach planning data and measurements for device sizing.
The software can provide visualization of calcium.
The user can generate tortuosity calculations along a centerline.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122578: Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) Planning.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122578
Report an extraction error
Are you the manufacturer?
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