510(k) · Cleared
ClearedIntegradweb by Dynamic Imaging, Inc.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynamic Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jun 20, 2003 as substantially equivalent to K013630 (Stentor, Inc., 2001) after a 57-day review. Its family tree reaches back 2 generations to 1994. 115 later devices descend from it.
- Decided
- Jun 20, 2003
- Review
- 57 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942120 (1994). 3 ancestors in all. 115 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 1 generation backK013630 Isite RadiologyStentor, Inc. · 2001
- This deviceK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- Descendant · cites it directly · 114 of its ownK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- Descendant · 2 generations on · 56 of its ownK052358 Etiam Star Pacs ComponentsEtiam, S.A. · 2005
- Descendant · 3 generations on · 55 of its ownK062488 IQ-System Pacs SystemImage Information Systems, Ltd. · 2006
- Descendant · 4 generations on · 49 of its ownK063470 Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007
- Descendant · 5 generations on · 44 of its ownK101342 Osirix MDPixmeo Sarl · 2010
Showing 5 of 115 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 115 · See all- K042313Integradweb MPR/MipDynamic Imaging, Inc. · 2004 · cites it directly114descendants
- K052358Etiam Star Pacs ComponentsEtiam, S.A. · 2005 · 2 generations on56descendants
- K062488IQ-System Pacs SystemImage Information Systems, Ltd. · 2006 · 3 generations on55descendants
- K063470Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007 · 4 generations on49descendants
- K101342Osirix MDPixmeo Sarl · 2010 · 5 generations on44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −1 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| 0 (this device) | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| +1 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| +2 | K052358 | Etiam Star Pacs Components | Etiam, S.A. | 2005 | — |
| +3 | K062488 | IQ-System Pacs System | Image Information Systems, Ltd. | 2006 | — |
| +4 | K063470 | Aycan Workstation Osirix | Aycan Digitalsysteme GmbH | 2007 | — |
| +5 | K101342 | Osirix MD | Pixmeo Sarl | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 8 | 0 |
| 2024 | 12 | 0 |
| 2025 | 11 | 0 |
| 2026 | 11 | 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? (1)
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 |
|---|---|---|---|
| * | K013630 | Isite Radiology | 2001 |
What descends from it? (115)
See all 1152 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 9 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K042313 (Dynamic Imaging, Inc., 2004) has gone furthest, with 114 descendants of its own.
- 6 other devices also cite its predicate K013630.
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?
INTEGRADWebTMby Dynamic Imaging, Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, as in physicians, nurses, and technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031311: Integradweb by Dynamic Imaging, Inc..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031311
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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