510(k) · Cleared
ClearedVeuron-Brain-pAb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heuron Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jan 15, 2021 as substantially equivalent to K121074 (Siemens Medical Solutions USA, Inc., 2012) and 1 other predicate after an 87-day review. Its family tree reaches back 7 generations to 1996. 5 later devices descend from it.
- Decided
- Jan 15, 2021
- Review
- 87 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K954874 (1996). 37 ancestors in all, the oldest K885054 (1989). 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 6 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 5 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 4 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 3 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 2 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 1 generation backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- This deviceK203142 Veuron-Brain-pAbHeuron Co., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK221405 Neurophet SCALE PETNeurophet., Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK252496 Neurophet AQUA AD PlusNeurophet., Inc. · 2026
- Descendant · cites it directly · 1 of its ownK213801 Veuron-Brain-pAb2Heuron Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK252563 Neurophet SCALE PETNeurophet., Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK231642 Veuron-Brain-pAb3Heuron Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K221405Neurophet SCALE PETNeurophet., Inc. · 2022 · cites it directly2descendants
- K252496Neurophet AQUA AD PlusNeurophet., Inc. · 2026 · 2 generations on1descendant
- K213801Veuron-Brain-pAb2Heuron Co., Ltd. · 2022 · cites it directly1descendant
- K252563Neurophet SCALE PETNeurophet., Inc. · 2026 · 2 generations on0descendants
- K231642Veuron-Brain-pAb3Heuron Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −6 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −5 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −4 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −3 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −2 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −1 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| 0 (this device) | K203142 | Veuron-Brain-pAb | Heuron Co., Ltd. | 2021 | — |
| +1 | K221405 | Neurophet SCALE PET | Neurophet., Inc. | 2022 | — |
| +2 | K252496 | Neurophet AQUA AD Plus | Neurophet., Inc. | 2026 | — |
| +1 | K213801 | Veuron-Brain-pAb2 | Heuron Co., Ltd. | 2022 | — |
| +2 | K252563 | Neurophet SCALE PET | Neurophet., Inc. | 2026 | — |
| +2 | K231642 | Veuron-Brain-pAb3 | Heuron Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K121074 | Scenium 2.0Summary page 4…g a variety of options for users to choose in the image process. Predicate Device < Primary predicate device > • Scenium 2.0 (Siemens Medical Solutions USA, Inc. K121074, 06/08/2012) < Secondary device > • MIM 4.0 (NEURO) (MlMvista Corp. K060816, 05/16/2006)… | 2012 |
| * | K060816 | Mim 4.0 (NeuroSummary page 4…ce < Primary predicate device > • Scenium 2.0 (Siemens Medical Solutions USA, Inc. K121074, 06/08/2012) < Secondary device > • MIM 4.0 (NEURO) (MlMvista Corp. K060816, 05/16/2006) 10 Heuron Co., Ltd. 10™ Floor, 7, Mirae-ro, Namdo… | 2006 |
What descends from it? (5)
2 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 25 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 37 ancestors have a recall of any class.
- Of its descendants, K221405 (Neurophet., Inc., 2022) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K121074.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Veuron-Brain-pAb is a software for the registration, fusion, display and analysis of medical images from multiple modalities including MRI and PET. The software aids clinician in the assessment and quantification of pathologies from PET Amyloid scans of the human brain. It enables automatic analysis and visualization of amyloid protein concentration through the calculation of standard uptake volume ratios (SUVR) within target regions of interest and comparison to those within the reference regions. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radio-tracer and disease combinations.
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/K203142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203142: Veuron-Brain-pAb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203142
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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