510(k) · Cleared
ClearedAquariusaps 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 May 15, 2006 as substantially equivalent to K012086 (Terarecon,Inc., 2001) and 3 other predicates after a 13-day review. Its family tree reaches back 6 generations to 1991. 1 of the 164 devices in its family, counting itself, has a Class I recall. 134 later devices descend from it.
- Decided
- May 15, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K913770 (1991). 29 ancestors in all. 134 later devices descend from it, 8 citing it directly. 1 of the 164 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 4 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 3 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 2 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 1 generation backK041807 Lung Car 1.1Medicsight · 2004
- This deviceK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- Descendant · cites it directly · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 2 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · 3 generations on · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
- Descendant · 4 generations on · 23 of its ownK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
- Descendant · 5 generations on · 21 of its ownK180336 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018
Showing 5 of 134 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…5 generations on · 2025
Most influential descendants
Showing 5 of 134 · See all- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · cites it directly99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 2 generations on63descendants
- K150843syngo®.via (version VB10A)Siemens AG · 2015 · 3 generations on46descendants
- K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017 · 4 generations on23descendants
- K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −4 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −3 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −2 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −1 | K041807 | Lung Car 1.1 | Medicsight | 2004 | — |
| 0 (this device) | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| +1 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +2 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +3 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| +4 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +5 | K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 9 | 0 |
| 2020 | 14 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 14 | 0 |
| 2024 | 14 | 0 |
| 2025 | 18 | 1 |
| 2026 | 15 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K011142 | FDA’s K011142 is Aquarius Workstation Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K012086 | Aquariusnet Server | 2001 |
| * | K041807 | Lung Car 1.1Summary page 1…90-LLZ Equivalent Device(s): 1. Aquarius Workstation-KO 1142 by TeraRecon Inc. 2. AquariusNETServer- KO12086 by TeraRecon lnc. 3. Lung CAR-K041807 by Medicsight PLC. 4. Colon CAR-K042674 by Medicsight PLC. 5. Fusion 7D-K020546 by Mirada Solutions, Ltd. Parts of these… | 2004 |
| * | K042674 | Colon Car 1.2Summary page 1…): 1. Aquarius Workstation-KO 1142 by TeraRecon Inc. 2. AquariusNETServer- KO12086 by TeraRecon lnc. 3. Lung CAR-K041807 by Medicsight PLC. 4. Colon CAR-K042674 by Medicsight PLC. 5. Fusion 7D-K020546 by Mirada Solutions, Ltd. Parts of these devices are substantially equivalent in term… | 2004 |
| * | K020546 | Fusion 7DSummary page 1…eraRecon Inc. 2. AquariusNETServer- KO12086 by TeraRecon lnc. 3. Lung CAR-K041807 by Medicsight PLC. 4. Colon CAR-K042674 by Medicsight PLC. 5. Fusion 7D-K020546 by Mirada Solutions, Ltd. Parts of these devices are substantially equivalent in terms of basic design, features and intended use… | 2002 |
What descends from it? (134)
See all 1348 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112020 | Syngo.CT Vascular Analysis | 2011 | 99 |
| K101662 | Synapse 3D Basic Tools | 2010 | 14 |
| K132853 | Novapacs | 2014 | 6 |
| K121916 | Intuition | 2013 | 5 |
| K131447 | Intuition - Tda, Tva, Parametric Mapping | 2013 | 2 |
| K242810 | RadUnity (Version 1.0.0) | 2024 | 0 |
| K210719 | Change Healthcare Anatomical AI | 2021 | 0 |
| K120734 | Microsoft Amalga Uis Image Processing Module | 2012 | 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 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K112020 (Siemens Medi Cal Solutions, Inc., 2011) has gone furthest, with 99 descendants of its own.
- 6 other devices also cite its predicate K012086.
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 AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol.…
Read the full statement (113 words)
The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061214: Aquariusaps Server.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061214
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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