510(k) · Cleared
ClearedNeuroq 3.6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntermed, Inc. · KPS System, Tomography, Computed, Emission
Cleared on May 17, 2013 as substantially equivalent to K072307 (Syntermed, Inc., 2008) and 2 other predicates after an 84-day review. Its family tree reaches back 8 generations to 2001. 1 later device descends from it.
- Decided
- May 17, 2013
- Review
- 84 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K010641 (2001). 18 ancestors in all, the oldest K914350 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 7 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 6 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 5 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 4 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 3 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 2 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 1 generation backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- This deviceK130451 Neuroq 3.6Syntermed, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK180077 NeuroQ 3.8Syntermed · 2018
Most influential descendants
Showing 1 of 1 · See all- K180077NeuroQ 3.8Syntermed · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −7 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −6 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −5 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −4 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −3 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −2 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −1 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| 0 (this device) | K130451 | Neuroq 3.6 | Syntermed, Inc. | 2013 | — |
| +1 | 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 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K072307 | Quantitative Neuroq 3.0Summary page 1…lay and Analysis program for PET Brain studies. Classification Name - System, Tomography, Computed, Emission 3. Medical Device Equivalence: NeuroQ Tm 3.0, Reference #: K072307 and Siemens Medical Solutions USA, Inc. Sceniumn 3.0, Reference #:K123528. 4. Device Description: NeuroQTM 3.6 has been develope… | 2008 |
| * | K123528 | SceniumSummary page 1…tem, Tomography, Computed, Emission 3. Medical Device Equivalence: NeuroQ Tm 3.0, Reference #: K072307 and Siemens Medical Solutions USA, Inc. Sceniumn 3.0, Reference #:K123528. 4. Device Description: NeuroQTM 3.6 has been developed to aid in the assessment of human brain scans through quantification of… | 2012 |
| * | K041022 | Neuroq - Pet DPSummary page 2…with some false positive and false negative results. The previous validation of the program can be found in the 510(k) submission for NeuroQTM - PET DIP, Ref. 510(k) #: K041022 and NeuroQTM 3.0 (510(k) #: K072307. The validation for modifications in version 3.6 can be found in Item H, Testing & Validation… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180077 | NeuroQ 3.8 | 2018 | 0 |
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 12 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K180077 (Syntermed, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072307.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
1) assist with regional assessment of human brain scans, through automated quantification of mean pixel values lying within standardized regions of interest (S-ROI's), and 2) assist with comparisons of the activity in brain regions of individual scans relative to normal activity values found for brain regions in FDG-PET scans, through quantitative and statistical comparisons of S-ROI's. 3) assist with comparisons of activity in brain regions of…
Read the full statement (151 words)
1) assist with regional assessment of human brain scans, through automated quantification of mean pixel values lying within standardized regions of interest (S-ROI's), and
2) assist with comparisons of the activity in brain regions of individual scans relative to normal activity values found for brain regions in FDG-PET scans, through quantitative and statistical comparisons of S-ROI's.
3) assist with comparisons of activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data
4) NeuroQ 3.6 provides added functionality to provide analysis of amyloid uptake levels in brain regions.
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/K130451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130451: Neuroq 3.6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130451
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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