510(k) · Cleared
ClearediSR'obot MRI-US Fusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biobot Surgical Pte., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Oct 6, 2016 as substantially equivalent to K120187 (Igt, LLC Dba Eigen, 2012) after a 169-day review. Its family tree reaches back 8 generations to 1993. 6 of the 89 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Oct 6, 2016
- Review
- 169 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K930090 (1993). 86 ancestors in all, the oldest K882383 (1988). 2 later devices descend from it, 1 citing it directly. 6 of the 89 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK930090 HelicatElscint, Inc. · 1993
- 7 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 6 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 5 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- 3 generations backK041182 SyntegraAdac Laboratories · 2004
- 2 generations backK081987 Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions · 2008
- 1 generation backK120187 Multi-Modality Image FusionIgt, LLC Dba Eigen · 2012
- This deviceK161109 iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK213411 iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK232320 iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2023
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −7 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −6 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −5 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −4 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| −3 | K041182 | Syntegra | Adac Laboratories | 2004 | — |
| −2 | K081987 | Unisyn Image Fusion, Version 1.0 | Convergent Imaging Solutions | 2008 | — |
| −1 | K120187 | Multi-Modality Image Fusion | Igt, LLC Dba Eigen | 2012 | — |
| 0 (this device) | K161109 | iSR'obot MRI-US Fusion | Biobot Surgical Pte., Ltd. | 2016 | — |
| +1 | K213411 | iSR’obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2021 | — |
| +2 | K232320 | iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2023 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K120187 | Multi-Modality Image FusionSummary page 7…, measurements and data reporting. Technology UroFusion employs the same fundamental scientific technology as that of its predicate device, Multi-modality Image Fusion (K120187). The majority of the software features and functions are common between the two products. The table below outlines the major sub… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213411 | iSR’obot Mona Lisa 2.0 | 2021 | 1 |
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 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 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 23 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 29 of the 86 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K213411 (Biobot Surgical Pte., Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K120187.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The iSR'obot MRI-US Fusion is a software application to be used by Clinicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of Magnetic Resonance and Ultrasound images for mapping planning information of the prostate gland and region of interest. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ delineation, region of interest delineation, landmark selection, measurements and data reporting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161109: iSR'obot MRI-US Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161109
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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