510(k) · Cleared
ClearedNeurophet SCALE PET
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurophet., Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 5, 2022 as substantially equivalent to K203142 (Heuron Co., Ltd., 2021) after an 81-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- Aug 5, 2022
- Review
- 81 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954874 (1996). 38 ancestors in all, the oldest K885054 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 7 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 6 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 5 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 4 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 3 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 2 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 1 generation backK203142 Veuron-Brain-pAbHeuron Co., Ltd. · 2021
- This deviceK221405 Neurophet SCALE PETNeurophet., Inc. · 2022
- Descendant · cites it directly · 1 of its ownK252496 Neurophet AQUA AD PlusNeurophet., Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252563 Neurophet SCALE PETNeurophet., Inc. · 2026
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 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −7 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −6 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −5 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −4 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −3 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −2 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −1 | K203142 | Veuron-Brain-pAb | Heuron Co., Ltd. | 2021 | — |
| 0 (this device) | K221405 | Neurophet SCALE PET | Neurophet., Inc. | 2022 | — |
| +1 | K252496 | Neurophet AQUA AD Plus | Neurophet., Inc. | 2026 | — |
| +1 | K252563 | Neurophet SCALE PET | Neurophet., Inc. | 2026 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K203142 | Veuron-Brain-pAbSummary page 5…a series of workflows which are specific to use with radio-tracer and disease combinations. 9. Predicate Device: • Primary Predicate: Veuron-Brain-pAb (K203142) by HEURON CO., LTD. • Reference Device: Scenium 2.0 (K121074) by Siemens Medical Solutions USA, Inc… | 2021 |
| † | K121074 | Scenium 2.0 | 2012 |
What descends from it? (2)
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 26 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 38 ancestors have a recall of any class.
- Of its descendants, K252496 (Neurophet., Inc., 2026) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K203142.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Neurophet SCALE PET 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/FDG 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 as stated in the FDA summary.
https://510kreport.com/device/K221405 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221405: Neurophet SCALE PET.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221405
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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