510(k) · Cleared
ClearedNeuroq - Pet DP
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 Jun 17, 2004 as substantially equivalent to K972886 (Segami Corp., Inc., 1997) and 1 other predicate after a 58-day review. Its family tree reaches back 2 generations to 1991. 1 of the 387 devices in its family, counting itself, has a Class I recall. 382 later devices descend from it.
- Decided
- Jun 17, 2004
- Review
- 58 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K914350 (1991). 4 ancestors in all. 382 later devices descend from it, 7 citing it directly. 1 of the 387 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK914350 Icon Computer SystemSiemens Gammasonics, Inc. · 1991 · Recalled
- 1 generation backK972886 MirageSegami Corp., Inc. · 1997
- This deviceK041022 Neuroq - Pet DPSyntermed, Inc. · 2004
- Descendant · cites it directly · 380 of its ownK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- Descendant · cites it directly · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 2 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 3 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 166 of its ownK062163 MimviewerMimvista Corp. · 2006
Showing 5 of 382 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 382 · See all- K042863SceniumSiemens Molecular Imaging, Ltd. · 2004 · cites it directly380descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · cites it directly350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 2 generations on287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on200descendants
- K062163MimviewerMimvista Corp. · 2006 · 2 generations on166descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914350 | Icon Computer System | Siemens Gammasonics, Inc. | 1991 | 1 |
| −1 | K972886 | Mirage | Segami Corp., Inc. | 1997 | — |
| 0 (this device) | K041022 | Neuroq - Pet DP | Syntermed, Inc. | 2004 | — |
| +1 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| +1 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +2 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 10 | 0 |
| 2013 | 8 | 0 |
| 2014 | 14 | 0 |
| 2015 | 13 | 0 |
| 2016 | 16 | 0 |
| 2017 | 18 | 0 |
| 2018 | 26 | 0 |
| 2019 | 23 | 0 |
| 2020 | 32 | 0 |
| 2021 | 25 | 0 |
| 2022 | 32 | 0 |
| 2023 | 33 | 0 |
| 2024 | 30 | 0 |
| 2025 | 41 | 1 |
| 2026 | 37 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K972886 | MirageSummary page 1…T scans, through quantitative and statistical comparisons of S-ROI's. 3. Medical Device Equivalence: Mirage/Modification to Mirage (NeuroGam TM ) Ref. 510(k) #'s:K972886 and K010726. 4. Device Description: The NeuroQTM - PET DP Display and Analysis Program has been developed to aid in the assessme… | 1997 |
| * | K010726 | Modification to MirageSummary page 1…through quantitative and statistical comparisons of S-ROI's. 3. Medical Device Equivalence: Mirage/Modification to Mirage (NeuroGam TM ) Ref. 510(k) #'s:K972886 and K010726. 4. Device Description: The NeuroQTM - PET DP Display and Analysis Program has been developed to aid in the assessment of human… | 2001 |
What descends from it? (382)
See all 3827 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K042863 (Siemens Molecular Imaging, Ltd., 2004) has gone furthest, with 380 descendants of its own.
- 3 other devices also cite its predicate K972886.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
NeuroQTM - PET DP Program is indicated to:
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 in 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041022: Neuroq - Pet DP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041022
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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