510(k) · Cleared
ClearedcNeuro cPET
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Combinostics OY · KPS System, Tomography, Computed, Emission
Cleared on Sep 14, 2023 as substantially equivalent to K141074 (Ge Medical Systems, LLC, 2014) after a 106-day review. Its family tree reaches back 7 generations to 2001. 1 later device descends from it.
- Decided
- Sep 14, 2023
- Review
- 106 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010641 (2001). 13 ancestors in all, the oldest K914350 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 6 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 5 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 4 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 3 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 2 generations backK062393 GE Vantage Pet Neuro SoftwareGE Healthcare · 2006
- 1 generation backK141074 Cortex ID SuiteGe Medical Systems, LLC · 2014
- This deviceK231576 cNeuro cPETCombinostics OY · 2023
- Descendant · cites it directly · 0 of its ownK261916 NeuroQuant PETCortechs Labs, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261916NeuroQuant PETCortechs Labs, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −6 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −5 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −4 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −3 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −2 | K062393 | GE Vantage Pet Neuro Software | GE Healthcare | 2006 | — |
| −1 | K141074 | Cortex ID Suite | Ge Medical Systems, LLC | 2014 | — |
| 0 (this device) | K231576 | cNeuro cPET | Combinostics OY | 2023 | — |
| +1 | K261916 | NeuroQuant PET | Cortechs Labs, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K141074 | Cortex ID SuiteSummary page 4…ON The cNeuro cPET is substantially equivalent to the following predicate: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K141074 CortexID Suite / GE Medical Systems, LLC 9 The predicate device have not been subject to a de… | 2014 |
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 |
|---|---|---|---|
| K261916 | NeuroQuant PET | 2026 | 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 22 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K261916 (Cortechs Labs, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
cNeuro cPET aids physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans. The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest and voxel-based maps of the brain. cNeuro cPET allows the user to…
Read the full statement (152 words)
cNeuro cPET aids physicians in the evaluation of patient pathologies via assessment and
quantification of PET brain scans.
The software aids in the assessment of human brain PET scans enabling automated analysis
through quantification of tracer uptake and comparison with the corresponding tracer uptake in
normal subjects. The resulting quantification is presented using volumes of interest and voxel-based
maps of the brain. cNeuro cPET allows the user to generate information regarding relative changes
in PET-FDG glucose metabolism.
cNeuro cPET additionally allows the user to generate information regarding relative changes in PET
brain amyloid load between a subject’s images and a hormal database, which may be the result of
brain neurodegeneration.
PET co-registration and fusion display capabilities with MRI allow PET findings to be related to brain
anatomy.
cNeuro cPET aids physicians in the image interpretation of PET studies conducted on patients being
evaluated for cognitive impairment, or other causes of cognitive decline.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231576: cNeuro cPET.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231576
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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