510(k) · Cleared
ClearedCortex ID Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · KPS System, Tomography, Computed, Emission
Cleared on Sep 18, 2014 as substantially equivalent to K062393 (GE Healthcare, 2006) after a 146-day review. Its family tree reaches back 6 generations to 2001. 2 later devices descend from it.
- Decided
- Sep 18, 2014
- Review
- 146 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010641 (2001). 12 ancestors in all, the oldest K914350 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 5 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 4 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 3 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 2 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 1 generation backK062393 GE Vantage Pet Neuro SoftwareGE Healthcare · 2006
- This deviceK141074 Cortex ID SuiteGe Medical Systems, LLC · 2014
- Descendant · cites it directly · 1 of its ownK231576 cNeuro cPETCombinostics OY · 2023
- Descendant · 2 generations on · 0 of its ownK261916 NeuroQuant PETCortechs Labs, Inc. · 2026
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 |
|---|---|---|---|---|---|
| −6 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −5 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −4 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −3 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −2 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −1 | K062393 | GE Vantage Pet Neuro Software | GE Healthcare | 2006 | — |
| 0 (this device) | K141074 | Cortex ID Suite | Ge Medical Systems, LLC | 2014 | — |
| +1 | K231576 | cNeuro cPET | Combinostics OY | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2023 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K062393 | GE Vantage Pet Neuro SoftwareSummary page 5…e: CortexID Suite Common/Usual Name: CortexID Suite Classification Names: 21CFR 892.1200, Radiology Product Code: KPS Predicate Device(s): K062393 - CortexID (originally called GE Vantage PET Neuro) Device Description: CortexID, image analysis software, has been devel… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231576 | cNeuro cPET | 2023 | 1 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K231576 (Combinostics OY, 2023) has gone furthest, with 1 descendant 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. 2014, 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?
CortexID software has been developed to aid 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, voxel-based or 3D stereotactic surface…
Read the full statement (196 words)
CortexID software has been developed to aid 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, voxel-based or 3D stereotactic surface projection maps of the brain. The package allows the user to gencrate information regarding relative changes in PET-FDG glucose metabolism.
CortexID Suite additionally allows the user to generate information in PET brain amyloid load between a subject’s images and a normal database, which may be the result of brain neurodegeneration.
PET co-registration and fusion display capabilities with CT and MR allow PET findings to be related to brain anatomy and offers visualization of structural abnormalities, which may result from brain injury, trauma, disorder, disease or dysfunction, such as subdural hematoma, tumor, stroke, or cerebrovascular disease, etc.
CortexID Suite may aid physicians in the image interpretation process of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline, and is an adjunct to other diagnostic evaluations.
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/K141074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141074: Cortex ID Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141074
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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