510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Vitrea 2, Version 2.1

K002519510(k) TraditionalCleared Oct 19, 200065-day reviewClass II21 CFR 892.2050Recalls 1

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

Vital Images, Inc. · LLZ System, Image Processing, Radiological

Cleared on Oct 19, 2000 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 271 later devices descend from it. It has been recalled once.

Decided
Oct 19, 2000
Review
65 days
Class
Class II
Product code
LLZ
Recalls
1
Predicates
0

271 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2009: 10 descendants cleared2004: 9 descendants cleared2003: 6 descendants cleared2002: 3 descendants cleared2001: 1 descendant cleared2006: 11 descendants cleared2008: 6 descendants cleared2013: 8 descendants cleared2012: 14 descendants cleared2018: 15 descendants cleared2014: 10 descendants cleared2019: 11 descendants cleared2010: 3 descendants cleared2011: 5 descendants cleared2015: 10 descendants cleared2005: 2 descendants cleared2021: 15 descendants cleared2017: 12 descendants cleared2007: 6 descendants cleared2022: 17 descendants cleared2016: 11 descendants cleared2024: 19 descendants cleared2023: 16 descendants cleared2025: 24 descendants cleared2026: 19 descendants cleared2020: 8 descendants cleared200020052010201520202025
  1. This deviceK002519 Vitrea 2, Version 2.1Vital Images, Inc. · 2000
  2. Descendant · cites it directly · 170 of its ownK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 164 of its ownK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
  4. Descendant · 2 generations on · 143 of its ownK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
  5. Descendant · 3 generations on · 117 of its ownK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
  6. Descendant · 4 generations on · 111 of its ownK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled

Showing 5 of 271 descendants. See all descendants

Descendants cleared per year

2001: 12002: 32003: 62004: 92005: 22006: 112007: 62008: 62009: 102010: 32011: 52012: 142013: 82014: 102015: 102016: 112017: 122018: 152019: 112020: 82021: 152022: 172023: 162024: 192025: 242026: 19
2001high 24 (2025) · low 1 (2001)2026

Most influential descendants

Showing 5 of 271 · See all
  • K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · cites it directly170descendants
  • K040305VITREA2 Version 3.5Vital Images, Inc. · 2004 · 2 generations on164descendants
  • K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · 2 generations on143descendants
  • K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · 3 generations on117descendants
  • K061624Vitrea, Version 3.9Vital Images, Inc. · 2006 · 4 generations on111descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002519Vitrea 2, Version 2.1Vital Images, Inc.2000—
+1K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.20032
+2K040305VITREA2 Version 3.5Vital Images, Inc.2004—
+2K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041
+3K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20052
+4K061624Vitrea, Version 3.9Vital Images, Inc.20061

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200230
200360
200490
200520
2006110
200760
200860
2009100
201030
201150
2012140
201380
2014100
2015100
2016110
2017120
2018150
2019110
202080
2021150
2022170
2023160
2024190
2025240
2026190
FIG. 1 — Lineage of K002519, 2000–2026Source: 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (271)

See all 271

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

NumberDeviceApplicantDecidedDescendants
K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.2003170
K032483Viatronix V3D Explorer, Revision 1.2Viatronix, Inc.200376
K031871AutoboneGe Medical Systems Europe200358
K033361Viatronix V3D Vascular, Revision 1.0Viatronix, Inc.200322
K031779CadstreamConfirma, Inc.200319
K041286Dynacad V1.0Mri Devices Corp.200417
K020658Viatronix V3D ColonViatronix, Inc.20024
K040746Mra-CMSMedis Medical Imaging Systems BV20042
K040126Viatronix V3D Colon, Revision 1.3Viatronix, Inc.20042
K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.20091

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 5, 2013Class IIZ-1002-2013Software designVital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K032748 (Vital Images, Inc., 2003) has gone furthest, with 170 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—

More from Vital Images, Inc.

41 FDA decisions under this applicant name. See the company

  • K181247Vitrea CT Brain PerfusionVital Images, Inc. · 2018
  • K182230Multi Modality ViewerVital Images, Inc. · 2018
  • K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc. · 2017
  • K163232Vitrea ViewVital Images, Inc. · 2017
  • K163574Multi Modality ViewerVital Images, Inc. · 2017

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • 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/K002519 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002519: Vitrea 2, Version 2.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002519

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026