510(k) Report

510(k) · Cleared

Cleared

Voxar 3D Enterprise, Model 6.1

K060505510(k) SpecialCleared Mar 29, 200630-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Barcoview Mis Edinburgh · LLZ System, Image Processing, Radiological

Cleared on Mar 29, 2006 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 59 later devices descend from it.

Decided
Mar 29, 2006
Review
30 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

59 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2010: 1 descendant cleared2015: 2 descendants cleared2009: 1 descendant cleared2012: 1 descendant cleared2018: 2 descendants cleared2016: 2 descendants cleared2014: 2 descendants cleared2013: 2 descendants cleared2021: 3 descendants cleared2026: 9 descendants cleared2020: 3 descendants cleared2025: 10 descendants cleared2023: 4 descendants cleared2019: 3 descendants cleared2024: 5 descendants cleared2022: 6 descendants cleared2017: 1 descendant cleared20052010201520202025
  1. This deviceK060505 Voxar 3D Enterprise, Model 6.1Barcoview Mis Edinburgh · 2006
  2. Descendant · cites it directly · 51 of its ownK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
  3. Descendant · 2 generations on · 49 of its ownK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
  4. Descendant · 3 generations on · 19 of its ownK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
  5. Descendant · 3 generations on · 16 of its ownK141475 EndosizeTherenva Sas · 2014
  6. Descendant · 4 generations on · 13 of its ownK160376 EndoSizeTherenva Sas · 2016

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2008: 22009: 12010: 12012: 12013: 22014: 22015: 22016: 22017: 12018: 22019: 32020: 32021: 32022: 62023: 42024: 52025: 102026: 9
2008high 10 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 59 · 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060505Voxar 3D Enterprise, Model 6.1Barcoview Mis Edinburgh2006—
+1K0726533VISEON/Surgery3Mensio Medical Imaging BV2008—
+2K1203673MENSIO WorkstationPie Medical Imaging BV2012—
+3K1537363mensio WorkstationPie Medical Imaging BV20161
+3K141475EndosizeTherenva Sas2014—
+4K160376EndoSizeTherenva Sas2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200910
201010
201210
201320
201420
201520
201620
201710
201820
201930
202030
202130
202260
202340
202450
2025100
202690
FIG. 1 — Lineage of K060505, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (59)

See all 59

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K0726533VISEON/Surgery3Mensio Medical Imaging BV200851
K143318DR Systems Zero Download 3D Viewer (Z3D)Dr Systems, Inc.20154
K082041Fiatlux VisualizeFiatlux Imaging, Inc.20081
K102435Beyondimage WorkstationNeusoft Medical Systems Co., Ltd.20100

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?

  • Of its descendants, K072653 (3Mensio Medical Imaging BV, 2008) has gone furthest, with 51 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

The Voxar 3D product family is a suite of products that is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpreting DICOM compliant tomographic medical imaging. The Voxar 3D product family provides several levels of functionality to the user * Basic analysis tools they use on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab…

Read the full statement (197 words)

The Voxar 3D product family is a suite of products that is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpreting DICOM compliant tomographic medical imaging.

The Voxar 3D product family provides several levels of functionality to the user

* Basic analysis tools they use on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AveIP, MIP, MinIP, measurements, annotations, reporting, distribution, etc

* Tools for in-depth analysis, such as segmentation, endoscopic review, colour VR slab, 3D volume review, path definition and boundary detection, PET imagery analysis, etc

* Specialist tools and workdflow enhancements for specific clinical applications which provide targeted workflows, custom Ul, targeted measurement and reporting functions including Colon Screening (which is intended for the screening of patients for colonic polyps, turnours and other lesions using tomographic Colonography), Calcium Scoring (which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms), Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc-

Indications for use as stated in the FDA 510(k) statement.

More from Barcoview Mis Edinburgh

3 FDA decisions under this applicant name. See the company

  • K070831Voxar 3D Enterprise with Colonmetrix and Pet/CT PerfusionBarcoview Mis Edinburgh · 2007
  • K061326Voxar 3D Enterprise with CardiametrixBarcoview Mis Edinburgh · 2006

Recent decisions in LLZ

The LLZ category page

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  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K060505 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060505: Voxar 3D Enterprise, Model 6.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060505

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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