510(k) · Cleared
ClearedQuantitative Neuroq 3.0
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 Mar 14, 2008 as substantially equivalent to K041022 (Syntermed, Inc., 2004) after a 210-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- Mar 14, 2008
- Review
- 210 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K914350 (1991). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK914350 Icon Computer SystemSiemens Gammasonics, Inc. · 1991 · Recalled
- 2 generations backK972886 MirageSegami Corp., Inc. · 1997
- 1 generation backK041022 Neuroq - Pet DPSyntermed, Inc. · 2004
- This deviceK072307 Quantitative Neuroq 3.0Syntermed, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK130451 Neuroq 3.6Syntermed, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK180077 NeuroQ 3.8Syntermed · 2018
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 |
|---|---|---|---|---|---|
| −3 | K914350 | Icon Computer System | Siemens Gammasonics, Inc. | 1991 | 1 |
| −2 | K972886 | Mirage | Segami Corp., Inc. | 1997 | — |
| −1 | K041022 | Neuroq - Pet DP | Syntermed, Inc. | 2004 | — |
| 0 (this device) | K072307 | Quantitative Neuroq 3.0 | Syntermed, Inc. | 2008 | — |
| +1 | 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 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K041022 | Neuroq - Pet DPSummary page 1…nd Analysis program for PET Brain studies. Classification Name - System, Tomography, Computed, Emission 3. Medical Device Equivalence: NeuroQTM - PET DP, Ref.510(k)#: K041022 4. Device Description: NeuroQTM 3.0 has been developed to aid in the assessment of human brain scans through quantification of m… | 2004 |
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 17 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K130451 (Syntermed, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 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. 2008, 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 NeuroQTM-PET DP program is indicated to perform a quantitative analysis of FDG-PET brain scans using a RO count method.
NeuroQTM 3.0 provides added functionality which allows for analyzing the difference between two FDG-PET brain studies for the same patient, calculating values within user defined regions of interest, and displaying CT and PET brain studies for the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072307 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072307: Quantitative Neuroq 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072307
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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