510(k) · Cleared
ClearedNeuroQ 3.8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntermed · KPS System, Tomography, Computed, Emission
Cleared on Aug 16, 2018 as substantially equivalent to K041022 (Syntermed, Inc., 2004) and 4 other predicates after a 218-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Aug 16, 2018
- Review
- 218 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K010641 (2001). 26 ancestors in all, the oldest K914350 (1991). No later device cites it as a predicate yet.
- Root · 10 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 6 generations between
- 3 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 2 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 1 generation backK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- This deviceK180077 NeuroQ 3.8Syntermed · 2018
Show all 10 generations
- Root · 10 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 9 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 8 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 7 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 6 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 5 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 4 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 3 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 2 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 1 generation backK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- This deviceK180077 NeuroQ 3.8Syntermed · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −9 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −8 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −7 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −6 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −5 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −4 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −3 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −2 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| −1 | K153355 | Xeleris 4.0 Processing and Review Workstation | GE Healthcare | 2016 | — |
| 0 (this device) | K180077 | NeuroQ 3.8 | Syntermed | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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.
Planning a device in KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K041022 | Neuroq - Pet DPSummary page 6…roQ™ 3.8 provides a program which executes in the IDL operating system environment and we believe is substantially equivalent to our previous version of NeuroQ™ - PET DP K041022, NeuroQ™ 3.0 (510(k) #: K072307, NeuroQ™ 3.6 (510(k) #: K130451, and Hermes Medical Solutions AB, Hermes Medical Imaging Suite v5… | 2004 |
| * | K072307 | Quantitative Neuroq 3.0Summary page 6…h executes in the IDL operating system environment and we believe is substantially equivalent to our previous version of NeuroQ™ - PET DP K041022, NeuroQ™ 3.0 (510(k) #: K072307, NeuroQ™ 3.6 (510(k) #: K130451, and Hermes Medical Solutions AB, Hermes Medical Imaging Suite v5.2, Reference K121278. To our kn… | 2008 |
| * | K130451 | Neuroq 3.6Summary page 4…Analysis program for PET Brain studies. Classification Name – System, Tomography, Computed, Emission 3. Medical Device Equivalence: NeuroQ™ 3.6, Reference #: K130451 Hermes Medical Solutions AB, Hermes Medical Imaging Suite v5.2, Reference #: K121278. General Electric Xel… | 2013 |
| * | K121278 | Hermes Medical Imaging Suite V5.2Summary page 4…on 3. Medical Device Equivalence: NeuroQ™ 3.6, Reference #: K130451 Hermes Medical Solutions AB, Hermes Medical Imaging Suite v5.2, Reference #: K121278. General Electric Xeleris 4.0 Processing and Review Workstation, Reference #: K153355. 4. Device Description: Ne… | 2012 |
| * | K153355 | Xeleris 4.0 Processing and Review WorkstationSummary page 4…Solutions AB, Hermes Medical Imaging Suite v5.2, Reference #: K121278. General Electric Xeleris 4.0 Processing and Review Workstation, Reference #: K153355. 4. Device Description: NeuroQ™ 3.8 has been developed to aid in the assessment of human brain scans through quantification of… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 26 ancestors have a recall of any class.
- 6 other devices also cite its predicate K041022.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The NeuroQ™ 3.8 program is used to regionally quantify activity in brain PET and SPECT scans using a ROI count method. It displays co-registered PET, SPECT and CT images, along with output from quantification of activities reflecting regional concentrations of FDG, amyloid imaging agents, SPECT perfusion and dopamine transporter radiotracers, relative to activities in any of several user-selected reference regions or whole brain. It provides for…
Read the full statement (197 words)
The NeuroQ™ 3.8 program is used to regionally quantify activity in brain PET and SPECT scans using a ROI count method. It displays co-registered PET, SPECT and CT images, along with output from quantification of activities reflecting regional concentrations of FDG, amyloid imaging agents, SPECT perfusion and dopamine transporter radiotracers, relative to activities in any of several user-selected reference regions or whole brain. It provides for displaying and quantifying the regional differences between two PET or SPECT brain studies for the same patient, or the levels of amyloid imaging agents retained in specified brain regions of a patient, and for assisting the user in the examination of brain scans acquired for assessing neurodegenerative processes underlying symptoms of cognitive and movement disorders by comparing regional activity values to each other and to those in brain scans acquired for asymptomatic control subjects. These neurodegenerative processes can be Alzheimer’s disease, Lewy body dementia, Parkinson’s disease with dementia, vascular dementia, and frontotemporal dementia.
The product is intended for use by trained nuclear technicians and nuclear medicine physicians. The clinician remains ultimately responsible for the final interpretation and diagnosis based on standard practices and visual interpretation of all SPECT and PET data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180077: NeuroQ 3.8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180077
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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