510(k) · Cleared
ClearediSR’obot Mona Lisa 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biobot Surgical Pte., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Dec 22, 2021 as substantially equivalent to K203659 (Biobot Surgical Pte., Ltd., 2021) and 2 other predicates after a 64-day review. Its family tree reaches back 9 generations to 1993. 6 of the 101 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Dec 22, 2021
- Review
- 64 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K930090 (1993). 99 ancestors in all, the oldest K864807 (1987). 1 later device descends from it, 1 citing it directly. 6 of the 101 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
- 5 generations between
- 3 generations backK081987 Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions · 2008
- 2 generations backK120187 Multi-Modality Image FusionIgt, LLC Dba Eigen · 2012
- 1 generation backK161109 iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd. · 2016
- This deviceK213411 iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK232320 iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2023
Show all 9 generations
- Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
- 8 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 7 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 6 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- 4 generations backK041182 SyntegraAdac Laboratories · 2004
- 3 generations backK081987 Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions · 2008
- 2 generations backK120187 Multi-Modality Image FusionIgt, LLC Dba Eigen · 2012
- 1 generation backK161109 iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd. · 2016
- This deviceK213411 iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −8 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −7 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −6 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −5 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| −4 | K041182 | Syntegra | Adac Laboratories | 2004 | — |
| −3 | K081987 | Unisyn Image Fusion, Version 1.0 | Convergent Imaging Solutions | 2008 | — |
| −2 | K120187 | Multi-Modality Image Fusion | Igt, LLC Dba Eigen | 2012 | — |
| −1 | K161109 | iSR'obot MRI-US Fusion | Biobot Surgical Pte., Ltd. | 2016 | — |
| 0 (this device) | K213411 | iSR’obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2021 | — |
| +1 | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 1 |
| 1997 | 5 | 0 |
| 1998 | 10 | 3 |
| 1999 | 5 | 0 |
| 2000 | 9 | 1 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 1 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K203659 | iSR'obot Mona Lisa 1.0Summary page 6…an. Predicate Device Information and Comparison Predicate Device Name Predicate 510(k) Submission Reference iSR’obot Mona Lisa 1.0 K203659 (Primary) iSR’obot MRI-US Fusion K161109 (Reference) iSR’obot Biopsy Kit K163502 (Referenc… | 2021 |
| * | K161109 | iSR'obot MRI-US FusionSummary page 6…e Device Name Predicate 510(k) Submission Reference iSR’obot Mona Lisa 1.0 K203659 (Primary) iSR’obot MRI-US Fusion K161109 (Reference) iSR’obot Biopsy Kit K163502 (Reference) Artemis K162474 (Refere… | 2016 |
| * | K163502 | iSR'obot Biopsy KitSummary page 6…eference iSR’obot Mona Lisa 1.0 K203659 (Primary) iSR’obot MRI-US Fusion K161109 (Reference) iSR’obot Biopsy Kit K163502 (Reference) Artemis K162474 (Reference) Intended Use / Indications for Use iSR’obot Mona Lis… | 2017 |
| † | K162474 | Artemis | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232320 | iSR`obot Mona Lisa 2.0 | 2023 | 0 |
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 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 4 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 28 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 30 of the 99 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K232320 (Biobot Surgical Pte., Ltd., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
iSR’obot Mona Lisa 2.0 is a user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a third-party needle or a probe, during image-guided diagnostic and interventional procedures in conjunction with the guidance of transrectal ultrasound involving the prostate gland in a clinical setting. Examples of such procedures include, but are not limited to, image fusion for diagnostic clinical…
Read the full statement (161 words)
iSR’obot Mona Lisa 2.0 is a user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a third-party needle or a probe, during image-guided diagnostic and interventional procedures in conjunction with the guidance of transrectal ultrasound involving the prostate gland in a clinical setting. Examples of such procedures include, but are not limited to, image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, and soft tissue ablations.
The iSR’obot Mona Lisa 2.0 provides 2D and 3D visualization of Ultrasound images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance, etc. It also provides the ability to display a simulated image of an insertion tool on a computer monitor screen, the target organ, and the current and projected future path of the insertion tool taking into account patient movement. Other software features include multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, and reporting.
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/K213411 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213411: iSR’obot Mona Lisa 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213411
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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