510(k) · Cleared
ClearedIconnection, Version 3.2.0.0 Medical Image Processing Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Images, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 19, 2004 as substantially equivalent to K032748 (Vital Images, Inc., 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 1991. 30 later devices descend from it.
- Decided
- Apr 19, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K913770 (1991). 19 ancestors in all, the oldest K896095 (1990). 30 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 1 generation backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- This deviceK040876 Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareVital Images, Inc. · 2004
- Descendant · cites it directly · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011
- Descendant · cites it directly · 12 of its ownK062154 Vital Connect 4.0Vital Images, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 11 of its ownK071362 Vital Connect 4.1Vital Images, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 10 of its ownK133993 Caas WorkstationPie Medical Imaging · 2014
- Descendant · 3 generations on · 9 of its ownK151780 CAAS WorkstationPie Medical Imaging BV · 2016
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K110256The IC-Pro SystemPaieon, Inc. · 2011 · cites it directly15descendants
- K062154Vital Connect 4.0Vital Images, Inc. · 2006 · cites it directly12descendants
- K071362Vital Connect 4.1Vital Images, Inc. · 2007 · 2 generations on11descendants
- K133993Caas WorkstationPie Medical Imaging · 2014 · 2 generations on10descendants
- K151780CAAS WorkstationPie Medical Imaging BV · 2016 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −1 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| 0 (this device) | K040876 | Iconnection, Version 3.2.0.0 Medical Image Processing Software | Vital Images, Inc. | 2004 | — |
| +1 | K110256 | The IC-Pro System | Paieon, Inc. | 2011 | — |
| +1 | K062154 | Vital Connect 4.0 | Vital Images, Inc. | 2006 | 4 |
| +2 | K071362 | Vital Connect 4.1 | Vital Images, Inc. | 2007 | 3 |
| +2 | K133993 | Caas Workstation | Pie Medical Imaging | 2014 | — |
| +3 | K151780 | CAAS Workstation | Pie Medical Imaging BV | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K032748 | VITREA2, Version 3.4 Medical Image Processing SoftwareSummary page 1…stem, Image Processing, Radiological Name Classification Name LLZ, Class II,CFR 21 892.2050 Vitrea 2, Version 3.4 (K032748) Vital Images, Inc. iConnection (K012779)… | 2003 |
| * | K012779 | Iconnection 3DSummary page 1…Vitrea 2, Version 3.4 (K032748) Vital Images, Inc. iConnection (K012779) Hinnovation, Inc. Device Description iConnection provides an online enterprise solution f… | 2001 |
What descends from it? (30)
See all 303 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K110256 (Paieon, Inc., 2011) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K032748.
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?
iConnection 3D1 is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. In addition, the iConnection system has the following specific intended uses: Advanced Vessel Analysis is an option within the iConnection system intended to aid clinicians in the study and analysis of selected…
Read the full statement (215 words)
iConnection 3D1 is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. In addition, the iConnection system has the following specific intended uses:
Advanced Vessel Analysis is an option within the iConnection system intended to aid clinicians in the study and analysis of selected vessels, the inspection of circulatory anatomy, the quantification of stenosis, distance measurements and cross-sectional diameters, volume measurements, and assist in the planning and monitoring of vascular therapies. The feature operates with CT and MRI data.
Pet Visualization is an option within the iConnection system that provides for the overlay, inspection, and measurement of two different image modalities (primarily directed at PET/CT). The option also includes the ability to measure Standard Uptake Values on PET datasets.
The overlay operation enables clinicians to obtain a better understanding of the joint information that would otherwise have to be compared separately. It is important to note that the clinician retains the ultimate responsibility for making pertinent diagnosis based on their standard procedures, including visual comparison of separate images.
Collaboration Mode is a capability within the iConnection system that allows multiple users to collaboratively interact with iConnection system features and tools.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040876: Iconnection, Version 3.2.0.0 Medical Image Processing Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040876
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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