510(k) · Cleared
ClearedTARGET3D Fusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convergent Life Sciences, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 27, 2014 as substantially equivalent to K120187 (Igt, LLC Dba Eigen, 2012) and 2 other predicates after a 51-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.
- Decided
- Feb 27, 2014
- Review
- 51 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K930090 (1993). 88 ancestors in all, the oldest K882383 (1988). No later device cites it as a predicate yet. 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 deviceK140033 TARGET3D FusionConvergent Life Sciences, Inc. · 2014
Class I recalls in this family
View 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) | 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 |
| 2010 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K120187 | Multi-Modality Image FusionSummary page 1…LZ Predicate Devices: Device Name 510(k) Number Multi-Modality Image Fusion K120187 UROISTATION-31D Prostate Suite K131448 Synt… | 2012 |
| * | K131448 | 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS…Summary page 1…Number Multi-Modality Image Fusion K120187 UROISTATION-31D Prostate Suite K131448 Syntegra K041182 Intended Use target3D Fusion is a soft… | 2013 |
| * | K041182 | SyntegraSummary page 1…K120187 UROISTATION-31D Prostate Suite K131448 Syntegra K041182 Intended Use target3D Fusion is a software application intended to be used by physicians in a clinic or hospital for visu… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 29 of the 88 ancestors have a recall of any class; 6 have a Class I recall.
- 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. 2014, 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?
target3D Fusion is a software application intended to be used by physicians in a clinic or hospital for visualization in 2D and 3D, registration, and fusion of Ultrasound (US), Magnetic Resonance (MR) and Computed Tomography (CT) images of the prostate. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ and regions of interest delineation, landmark selection, measurements, patient database management, and data reporting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140033: TARGET3D Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140033
Report an extraction error
Are you the manufacturer?
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