510(k) · Cleared
ClearedIconnection 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hinnovation, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 2, 2001 as substantially equivalent to K992654 (Voxar Limited, 1999) and 2 other predicates after a 74-day review. Its family tree reaches back 3 generations to 1990. 31 later devices descend from it.
- Decided
- Nov 2, 2001
- Review
- 74 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K896095 (1990). 7 ancestors in all. 31 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 2 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 1 generation backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- This deviceK012779 Iconnection 3DHinnovation, Inc. · 2001
- Descendant · cites it directly · 30 of its ownK040876 Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareVital Images, Inc. · 2004
- Descendant · 2 generations on · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011
- Descendant · 2 generations on · 12 of its ownK062154 Vital Connect 4.0Vital Images, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 11 of its ownK071362 Vital Connect 4.1Vital Images, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 10 of its ownK133993 Caas WorkstationPie Medical Imaging · 2014
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K040876Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareVital Images, Inc. · 2004 · cites it directly30descendants
- K110256The IC-Pro SystemPaieon, Inc. · 2011 · 2 generations on15descendants
- K062154Vital Connect 4.0Vital Images, Inc. · 2006 · 2 generations on12descendants
- K071362Vital Connect 4.1Vital Images, Inc. · 2007 · 3 generations on11descendants
- K133993Caas WorkstationPie Medical Imaging · 2014 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −2 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −1 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| 0 (this device) | K012779 | Iconnection 3D | Hinnovation, Inc. | 2001 | — |
| +1 | K040876 | Iconnection, Version 3.2.0.0 Medical Image Processing Software | Vital Images, Inc. | 2004 | — |
| +2 | K110256 | The IC-Pro System | Paieon, Inc. | 2011 | — |
| +2 | K062154 | Vital Connect 4.0 | Vital Images, Inc. | 2006 | 4 |
| +3 | K071362 | Vital Connect 4.1 | Vital Images, Inc. | 2007 | 3 |
| +3 | K133993 | Caas Workstation | Pie Medical Imaging | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K992654 | Plug 'N View 3D, Version 1.0Summary page 1…ction 3D Picture Archiving and Communication System Class II Medical Device; (21 CFR 892.2050) Product Code: LLZ Panel: 90 Voxar Limited (PLUG ‘N VIEW 3D, Version 1.0; K992654) and Applicare Medical Imaging, B.V, as described in K982862 and K962699; Device description: iConnection 3D is a picture archiv… | 1999 |
| * | K982862 | Radworks Medical Imaging Software with Quality Control ModuleSummary page 1…Medical Device; (21 CFR 892.2050) Product Code: LLZ Panel: 90 Voxar Limited (PLUG ‘N VIEW 3D, Version 1.0; K992654) and Applicare Medical Imaging, B.V, as described in K982862 and K962699; Device description: iConnection 3D is a picture archiving and communications system as described in 21 CFR 892.205… | 1998 |
| * | K962699 | Radworks Medical Imaging SoftwareSummary page 1…ice; (21 CFR 892.2050) Product Code: LLZ Panel: 90 Voxar Limited (PLUG ‘N VIEW 3D, Version 1.0; K992654) and Applicare Medical Imaging, B.V, as described in K982862 and K962699; Device description: iConnection 3D is a picture archiving and communications system as described in 21 CFR 892.2050. Indicati… | 1996 |
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040876 | Iconnection, Version 3.2.0.0 Medical Image Processing Software | 2004 | 30 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K040876 (Vital Images, Inc., 2004) has gone furthest, with 30 descendants of its own.
- 15 other devices also cite its predicate K992654.
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 3D is a software application intended for integrated processing and distribution of 2D and 3D digitized data derived from CT and MRI (and others) scans for use by radiologists, clinicians, and other professionals to acquire, process, render, review, store, print, and distribute DICOM 3.0 compliant images utilizing standard PC hardware with MS 98, NT, or MS 2000 operating systems.
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/K012779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012779: Iconnection 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012779
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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