510(k) · Cleared
ClearedAquariusnet Server
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terarecon,Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 13, 2001 as substantially equivalent to K972903 (Imatron, Inc., 1997) and 1 other predicate after a 72-day review. Its family tree reaches back 3 generations to 1995. 1 of the 212 devices in its family, counting itself, has a Class I recall. 207 later devices descend from it.
- Decided
- Sep 13, 2001
- Review
- 72 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945188 (1995). 4 ancestors in all. 207 later devices descend from it, 7 citing it directly. 1 of the 212 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 2 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 1 generation backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- This deviceK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- Descendant · cites it directly · 134 of its ownK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- Descendant · 2 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 3 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · 4 generations on · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
- Descendant · cites it directly · 36 of its ownK072205 Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007
Showing 5 of 207 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…6 generations on · 2025
Most influential descendants
Showing 5 of 207 · See all- K061214Aquariusaps ServerTerarecon,Inc. · 2006 · cites it directly134descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 2 generations on99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 3 generations on63descendants
- K150843syngo®.via (version VB10A)Siemens AG · 2015 · 4 generations on46descendants
- K072205Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007 · cites it directly36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −2 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −1 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| 0 (this device) | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| +1 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| +2 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +3 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +4 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| +1 | K072205 | Visage Pacs/CS, Release Version 5.0 | Mercury Computer Systems, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 9 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 12 | 0 |
| 2019 | 10 | 0 |
| 2020 | 21 | 0 |
| 2021 | 10 | 0 |
| 2022 | 15 | 0 |
| 2023 | 17 | 0 |
| 2024 | 21 | 0 |
| 2025 | 22 | 1 |
| 2026 | 17 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K972903 | Imatron Ultra Access Workstation with Cardiac Software ExtensionsSummary page 1…. Class I, proposed exempt, final rule pending. ProCode(s): 90-LLZ & 90-LMD Equivalent Device(s): 1. Imatron Ultra Access Workstation with Cardiac Software Extensions (K972903). 2. LiVS™ Integrated image Viewing Station (K994329). These devices are substantially equivalent in terms of basic design, fea… | 1997 |
| * | K994329 | Iivs Integrated Image Viewing StationSummary page 1…de(s): 90-LLZ & 90-LMD Equivalent Device(s): 1. Imatron Ultra Access Workstation with Cardiac Software Extensions (K972903). 2. LiVS™ Integrated image Viewing Station (K994329). These devices are substantially equivalent in terms of basic design, features and intended use. Description of the Device: Aq… | 2000 |
What descends from it? (207)
See all 2077 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061214 | Aquariusaps Server | 2006 | 134 |
| K072205 | Visage Pacs/CS, Release Version 5.0 | 2007 | 36 |
| K081985 | AW Server | 2008 | 27 |
| K062490 | Visage Pacs/CS, Release Version 4.1 | 2006 | 7 |
| K121916 | Intuition | 2013 | 5 |
| K051809 | Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management System | 2005 | 2 |
| K060035 | Mdxnet | 2006 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K061214 (Terarecon,Inc., 2006) has gone furthest, with 134 descendants of its own.
- 4 other devices also cite its predicate K972903.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The AquariusNET Server acquires, stores, transmits, and enables compatible
computers on a network to display medical images from medical scanning devices
such as EBT, CT or MRI and patient reports of various types. Teleradiology,
image acquisition, distribution, archiving, image manipulation, 3D and 4D
visualization are supported. Calcium scoring from whole body computed
tomography derived measurements, for non-invasive detection and quantification
of atherosclerotic plaque. Tools for histogram analysis of the density distribution
of certain regions of interest are provided. A database management and report
generation tool is included.
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/K012086 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012086: Aquariusnet Server.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012086
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026