510(k) · Cleared
ClearedUnisyn Image Fusion, Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convergent Imaging Solutions · LLZ System, Image Processing, Radiological
Cleared on Sep 26, 2008 as substantially equivalent to K041182 (Adac Laboratories, 2004) and 1 other predicate after a 74-day review. Its family tree reaches back 6 generations to 1993. 7 later devices descend from it.
- Decided
- Sep 26, 2008
- Review
- 74 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K930090 (1993). 15 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK930090 HelicatElscint, Inc. · 1993
- 5 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 4 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 3 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- 1 generation backK041182 SyntegraAdac Laboratories · 2004
- This deviceK081987 Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions · 2008
- Descendant · cites it directly · 4 of its ownK120187 Multi-Modality Image FusionIgt, LLC Dba Eigen · 2012
- Descendant · 2 generations on · 2 of its ownK161109 iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd. · 2016
- Descendant · 3 generations on · 1 of its ownK213411 iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021
- Descendant · 4 generations on · 0 of its ownK232320 iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK231047 UniSyn Molecular Imaging (6-3-1)Convergent Imaging Solutions · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K120187Multi-Modality Image FusionIgt, LLC Dba Eigen · 2012 · cites it directly4descendants
- K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd. · 2016 · 2 generations on2descendants
- K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021 · 3 generations on1descendant
- K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2023 · 4 generations on0descendants
- K231047UniSyn Molecular Imaging (6-3-1)Convergent Imaging Solutions · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −5 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −4 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −3 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −2 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| −1 | K041182 | Syntegra | Adac Laboratories | 2004 | — |
| 0 (this device) | K081987 | Unisyn Image Fusion, Version 1.0 | Convergent Imaging Solutions | 2008 | — |
| +1 | K120187 | Multi-Modality Image Fusion | Igt, LLC Dba Eigen | 2012 | — |
| +2 | K161109 | iSR'obot MRI-US Fusion | Biobot Surgical Pte., Ltd. | 2016 | — |
| +3 | K213411 | iSR’obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2021 | — |
| +4 | K232320 | iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2023 | — |
| +1 | K231047 | UniSyn Molecular Imaging (6-3-1) | Convergent Imaging Solutions | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 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 |
|---|---|---|---|
| * | K041182 | SyntegraSummary page 2…Common Name: Syntegra Image Fusion Manufacturer: Philips Medical Systems 510K#: K041182 Comon Name: Medical Image Merge (Image Fusion) Manufactur… | 2004 |
| * | K001276 | Medical Image Merge (Mim)Summary page 2…Medical Image Merge (Image Fusion) Manufacturer: Syntermed (now MiM ista) 510K#: K001276 8. Technological Comparison to Predicate Devices: Feature Syntegra Medical… | 2000 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 6 of the 15 ancestors have a recall of any class.
- Of its descendants, K120187 (Igt, LLC Dba Eigen, 2012) has gone furthest, with 4 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. 2008, 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?
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT and MR scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081987: Unisyn Image Fusion, Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081987
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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