510(k) · Cleared
Recalled · Class II · 2015Intuition
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 Apr 2, 2013 as substantially equivalent to K011142 (Terarecon,Inc., 2001) and 4 other predicates after a 274-day review. Its family tree reaches back 7 generations to 1991. 5 later devices descend from it. It has been recalled once.
- Decided
- Apr 2, 2013
- Review
- 274 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 7 generations to K913770 (1991). 52 ancestors in all, the oldest K871859 (1987). 5 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 5 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 4 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 3 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 2 generations backK041807 Lung Car 1.1Medicsight · 2004
- 1 generation backK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- This deviceK121916 IntuitionTerarecon,Inc. · 2013
- Descendant · cites it directly · 2 of its ownK191585 iNtuition-Structural Heart ModuleTerarecon,Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK250337 AiORTA - PlanViTAA Medical Solutions, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK254207 AiORTA - Plan v2.0ViTAA Medical Solutions, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK200274 CariCloudCaristo Diagnostics · 2020
- Descendant · cites it directly · 0 of its ownK161061 IMPAX Volume Viewing 4.0Agfa Healthcare N.V. · 2016
Most influential descendants
Showing 5 of 5 · See all- K191585iNtuition-Structural Heart ModuleTerarecon,Inc. · 2019 · cites it directly2descendants
- K250337AiORTA - PlanViTAA Medical Solutions, Inc. · 2025 · 2 generations on1descendant
- K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc. · 2026 · 3 generations on0descendants
- K200274CariCloudCaristo Diagnostics · 2020 · cites it directly0descendants
- K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −5 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −4 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −2 | K041807 | Lung Car 1.1 | Medicsight | 2004 | — |
| −1 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| 0 (this device) | K121916 | Intuition | Terarecon,Inc. | 2013 | — |
| +1 | K191585 | iNtuition-Structural Heart Module | Terarecon,Inc. | 2019 | — |
| +2 | K250337 | AiORTA - Plan | ViTAA Medical Solutions, Inc. | 2025 | — |
| +3 | K254207 | AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. | 2026 | — |
| +1 | K200274 | CariCloud | Caristo Diagnostics | 2020 | — |
| +1 | K161061 | IMPAX Volume Viewing 4.0 | Agfa Healthcare N.V. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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.
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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011142 | Aquarius Workstation | 2001 |
| * | K012086 | Aquariusnet Server | 2001 |
| * | K061214 | Aquariusaps ServerSummary page 1…ercially available devices: Aquarius Workstation (KOl 11142), AquariusNET Server (KO 12086) AquariusAPS Server (K0612 14) VitreaView (K122 136), IQQA-Liver Software (K06 1696) Indications for Use:… | 2006 |
| * | K122136 | Vitreaview Cleared while this submission was under review Summary page 1…Aquarius Workstation (KOl 11142), AquariusNET Server (KO 12086) AquariusAPS Server (K0612 14) VitreaView (K122 136), IQQA-Liver Software (K06 1696) Indications for Use: To receive, store, transmit, post-p… | 2012 |
| * | K061696 | Iqqa-Liver SoftwareSummary page 1…AquariusNET Server (KO 12086) AquariusAPS Server (K0612 14) VitreaView (K122 136), IQQA-Liver Software (K06 1696) Indications for Use: To receive, store, transmit, post-process, display and allow manipulation of reports a… | 2006 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 21, 2015 | Class II | Z-1070-2015 | Software design | Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 9 of the 52 ancestors have a recall of any class.
- Of its descendants, K191585 (Terarecon,Inc., 2019) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K011142.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
To receive, store, transmit, post-process, display and allow manipulation of reports and medical images from acquisition devices, including optical or other non-DICOM format images, DICOM images with modality type XA, US, CR, DR, SPECT, NM and MG, and images from volumetric medical scanning devices such as EST, CT, PET or MRI. To provide access to images derived data and derived images via client-server software, web browser and mobile technology.…
Read the full statement (365 words)
To receive, store, transmit, post-process, display and allow manipulation of reports and medical images from acquisition devices, including optical or other non-DICOM format images, DICOM images with modality type XA, US, CR, DR, SPECT, NM and MG, and images from volumetric medical scanning devices such as EST, CT, PET or MRI. To provide access to images derived data and derived images via client-server software, web browser and mobile technology.
Visualization in 2D, 3D and 4D are supported for single or multiple datasets, or combinations thereof. Tools are provided to define and edit paths through structures such as centerlines, which may be used to analyze cross-sections of structures, or to provide flythrough visualizations rendered along such a centerline. Segmentation of regions of interest and quantitative analysis tools are provided, for images of vasculature, pathology and morphology, including distance, angle, volume, histogram, ratios thereof, and tracking of quantities over time. A database is provided to track and compare results using published comparison techniques such as RECIST and WHO. Calcium scoring for quantification of atherosclerotic plaque is supported.
Support is provided for digital image processing to derive metadata or new images from input image sets, for internal use or for forwarding to other devices using the DICOM protocol. Image processing tools are provided to extract metadata to derive parametric images from combinations of multiple input images, such as temporal phases, or images co-located in space but acquired with different imaging parameters, such as different MR pulse sequences, or different CT image parameters (e.g. dual energy).
iNtuition is designed for use by healthcare professionals and is intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions.
Interpretation of mammographic images or digitized film screen images is supported only when the software is used without compression and with an FDA-Approved monitor that offers at least SMpixel resolution and meets other technical specifications reviewed and accepted by the FDA.
iNtuitionMOBlLE provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. Not intended for diagnostic use when used via a web browser or mobile device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121916: Intuition.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121916
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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