510(k) · Cleared
ClearedMulti-Modality Image Fusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Igt, LLC Dba Eigen · LLZ System, Image Processing, Radiological
Cleared on Apr 6, 2012 as substantially equivalent to K041182 (Adac Laboratories, 2004) and 3 other predicates after a 74-day review. Its family tree reaches back 7 generations to 1993. 6 of the 90 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Apr 6, 2012
- Review
- 74 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K930090 (1993). 85 ancestors in all, the oldest K882383 (1988). 4 later devices descend from it, 2 citing it directly. 6 of the 90 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK930090 HelicatElscint, Inc. · 1993
- 6 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 5 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 4 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- 2 generations backK041182 SyntegraAdac Laboratories · 2004
- 1 generation backK081987 Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions · 2008
- This deviceK120187 Multi-Modality Image FusionIgt, LLC Dba Eigen · 2012
- Descendant · cites it directly · 2 of its ownK161109 iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK213411 iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK232320 iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK140033 TARGET3D FusionConvergent Life Sciences, Inc. · 2014
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd. · 2016 · cites it directly2descendants
- K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021 · 2 generations on1descendant
- K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2023 · 3 generations on0descendants
- K140033TARGET3D FusionConvergent Life Sciences, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −6 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −5 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −4 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −3 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| −2 | K041182 | Syntegra | Adac Laboratories | 2004 | — |
| −1 | K081987 | Unisyn Image Fusion, Version 1.0 | Convergent Imaging Solutions | 2008 | — |
| 0 (this device) | K120187 | Multi-Modality Image Fusion | Igt, LLC Dba Eigen | 2012 | — |
| +1 | K161109 | iSR'obot MRI-US Fusion | Biobot Surgical Pte., Ltd. | 2016 | — |
| +2 | K213411 | iSR’obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2021 | — |
| +3 | K232320 | iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2023 | — |
| +1 | K140033 | TARGET3D Fusion | Convergent Life Sciences, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 1 |
| 1997 | 3 | 0 |
| 1998 | 10 | 3 |
| 1999 | 5 | 0 |
| 2000 | 9 | 1 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 1 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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.
6 devices in this family have a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K041182 | SyntegraSummary page 1…, 21ICFR 892.2050 Predicate Devices: Device Name 510(k) Number Syntegra K04 1182 UniSyn K081987 Aegis Navigation… | 2004 |
| * | K081987 | Unisyn Image Fusion, Version 1.0Summary page 1…510(k) Number Syntegra K04 1182 UniSyn K081987 Aegis Navigation K093 672 Abaris… | 2008 |
| * | K093672 | Aegis Navigation Anda Egis Pelvic ApplicationSummary page 1…K04 1182 UniSyn K081987 Aegis Navigation K093 672 Abaris K053610 Intended Use Multi-Modality Image Fusion is a soft… | 2009 |
| * | K053610 | AbarisSummary page 1…K081987 Aegis Navigation K093 672 Abaris K053610 Intended Use Multi-Modality Image Fusion is a software application to be used by physicians in the clinic or hospital for 2-D a… | 2006 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 29 of the 85 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K161109 (Biobot Surgical Pte., Ltd., 2016) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K041182.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Multi-Modalitj Image Fusion is a software application to be used by physicians in the clinic or hospital for 2-0 and 3-0 visualization, image registration, and fusion of MRI, CT and Ultrasound imaging modalities for mapping planning information across modalities. Additional software features include database management, data communication, surface rendering, segmentation, regions of interest (ROI) delineation, volumetric measurements, and data reporting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120187 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120187: Multi-Modality Image Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120187
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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