510(k) Report

510(k) · Cleared

Cleared

Aquarius Workstation

K011142510(k) TraditionalCleared May 8, 200125-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

Terarecon,Inc. · LLZ System, Image Processing, Radiological

Cleared on May 8, 2001 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 211 later devices descend from it.

Decided
May 8, 2001
Review
25 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

211 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2009: 8 descendants cleared2005: 4 descendants cleared2011: 6 descendants cleared2012: 16 descendants cleared2008: 6 descendants cleared2013: 5 descendants cleared2002: 1 descendant cleared2004: 6 descendants cleared2003: 2 descendants cleared2021: 8 descendants cleared2006: 6 descendants cleared2015: 9 descendants cleared2010: 2 descendants cleared2026: 14 descendants cleared2020: 9 descendants cleared2019: 6 descendants cleared2016: 7 descendants cleared2007: 7 descendants cleared2014: 8 descendants cleared2017: 9 descendants cleared2025: 21 descendants cleared2022: 12 descendants cleared2024: 19 descendants cleared2018: 11 descendants cleared2023: 9 descendants cleared200020052010201520202025
  1. This deviceK011142 Aquarius WorkstationTerarecon,Inc. · 2001
  2. Descendant · cites it directly · 177 of its ownK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
  3. Descendant · 2 generations on · 170 of its ownK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
  4. Descendant · 3 generations on · 164 of its ownK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
  5. Descendant · 2 generations on · 143 of its ownK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
  6. Descendant · 3 generations on · 117 of its ownK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled

Showing 5 of 211 descendants. See all descendants

Descendants cleared per year

2002: 12003: 22004: 62005: 42006: 62007: 72008: 62009: 82010: 22011: 62012: 162013: 52014: 82015: 92016: 72017: 92018: 112019: 62020: 92021: 82022: 122023: 92024: 192025: 212026: 14
2002high 21 (2025) · low 1 (2002)2026

Most influential descendants

Showing 5 of 211 · See all
  • K023003Imagechecker-CT WorkstationR2 Technology, Inc. · 2002 · cites it directly177descendants
  • K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · 2 generations on170descendants
  • K040305VITREA2 Version 3.5Vital Images, Inc. · 2004 · 3 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011142Aquarius WorkstationTerarecon,Inc.2001—
+1K023003Imagechecker-CT WorkstationR2 Technology, Inc.2002—
+2K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.20032
+3K040305VITREA2 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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200460
200540
200660
200770
200860
200980
201020
201160
2012160
201350
201480
201590
201670
201790
2018110
201960
202090
202180
2022120
202390
2024190
2025210
2026140
FIG. 1 — Lineage of K011142, 2001–2026Source: 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
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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? (211)

See all 211

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

NumberDeviceApplicantDecidedDescendants
K023003Imagechecker-CT WorkstationR2 Technology, Inc.2002177
K082269Visage Pacs, Version 6.0/CS 3.1Visage Imaging, Inc.200820
K121916IntuitionTerarecon,Inc.20135
K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132
K051809Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management SystemMedical Insight A/S20052
K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120
K103720Synapse 3D Lung and Abdomen AnalysisFujifilm Medical Systems U.S.A, Inc.20110
K083691BonevueMicromri, Inc.20090

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, K023003 (R2 Technology, Inc., 2002) has gone furthest, with 177 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 Terarecon,Inc.

14 FDA decisions under this applicant name. See the company

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  • K220349TeraRecon NeuroTerarecon,Inc. · 2022
  • K200750Neuro.Al AlgorithmTerarecon,Inc. · 2020

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The LLZ category page

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https://510kreport.com/device/K011142 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011142: Aquarius Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011142

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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