510(k) · Cleared
ClearedIbis Explorer and Markup Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medqia · LLZ System, Image Processing, Radiological
Cleared on Aug 5, 2011 as substantially equivalent to K053133 (Siemens Medical Solutions USA, Inc., 2005) and 1 other predicate after an 87-day review. Its family tree reaches back 6 generations to 1995. 6 later devices descend from it.
- Decided
- Aug 5, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K950279 (1995). 37 ancestors in all, the oldest K913475 (1991). 6 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
- 5 generations backK964803 Univision Echocardiology SystemNetwork Concepts, Inc. · 1997
- 4 generations backK980060 EcholinkMpacs, LLC · 1998
- 3 generations backK992259 Echocardiography System Series 95000Camtronics, Ltd. · 1999
- 2 generations backK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · Recalled
- 1 generation backK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled
- This deviceK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
- Descendant · cites it directly · 5 of its ownK122205 EXINIExini Diagnostics AB · 2012
- Descendant · 2 generations on · 2 of its ownK191262 aBSIExini Diagnostics AB · 2019
- Descendant · 3 generations on · 1 of its ownK211655 aPROMISEExini Diagnostics AB · 2021
- Descendant · 2 generations on · 1 of its ownK173444 Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK233998 TRAQinform IQAiq Global, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122205EXINIExini Diagnostics AB · 2012 · cites it directly5descendants
- K191262aBSIExini Diagnostics AB · 2019 · 2 generations on2descendants
- K211655aPROMISEExini Diagnostics AB · 2021 · 3 generations on1descendant
- K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc. · 2018 · 2 generations on1descendant
- K233998TRAQinform IQAiq Global, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950279 | TOMTECP90 | Tomtec Imaging Systems, Inc. | 1995 | — |
| −5 | K964803 | Univision Echocardiology System | Network Concepts, Inc. | 1997 | — |
| −4 | K980060 | Echolink | Mpacs, LLC | 1998 | — |
| −3 | K992259 | Echocardiography System Series 95000 | Camtronics, Ltd. | 1999 | — |
| −2 | K041029 | Kinetdx | Siemens Medi Cal Solutions, Inc. | 2004 | 1 |
| −1 | K053133 | Syngo Dynamics, Version 5.0 | Siemens Medical Solutions USA, Inc. | 2005 | 2 |
| 0 (this device) | K111319 | Ibis Explorer and Markup Software | Medqia | 2011 | — |
| +1 | K122205 | EXINI | Exini Diagnostics AB | 2012 | — |
| +2 | K191262 | aBSI | Exini Diagnostics AB | 2019 | — |
| +3 | K211655 | aPROMISE | Exini Diagnostics AB | 2021 | — |
| +2 | K173444 | Quantitative Total Extensible Imaging (QTxI) | Aiq Solutions, Inc. | 2018 | — |
| +3 | K233998 | TRAQinform IQ | Aiq Global, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K053133 | Syngo Dynamics, Version 5.0Summary page 1…rkup Software are as follows: Trade Name 510(k) Submitter 510(k) Number syngo® Dynamics Siemens AG Medical K053133, cleared on Solutions December 5, 2005 VISAGEO PACS/CS 6.0 Mercury Computer Sys… | 2005 |
| * | K082269 | Visage Pacs, Version 6.0/CS 3.1Summary page 1…l K053133, cleared on Solutions December 5, 2005 VISAGEO PACS/CS 6.0 Mercury Computer System, K082269, cleared to market on Inc IDecember 12, 2008 5. Device Description The I… | 2008 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122205 | EXINI | 2012 | 5 |
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 16 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 37 ancestors have a recall of any class.
- Of its descendants, K122205 (Exini Diagnostics AB, 2012) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
IBIS Explorer and Markup Software is a Picture Archiving and Communication System (RAGS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Besides general image interpretation and processing tools, IBIS provides specific tool sets for several clinical applications, including:
* Oncology, including lesion marking and analysis
* Anatomic structure marking, volume measurement and analysis
Only DIGOM for presentation images can be used on an FDA approved monitor for mammography for image diagnosis.
Only uncompressed or non-lossy compressed images must be used for image diagnosis in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111319: Ibis Explorer and Markup Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111319
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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