510(k) · Cleared
ClearedGE Vantage Pet Neuro Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · KPS System, Tomography, Computed, Emission
Cleared on Sep 1, 2006 as substantially equivalent to K041022 (Syntermed, Inc., 2004) and 1 other predicate after a 16-day review. Its family tree reaches back 5 generations to 2001. 3 later devices descend from it.
- Decided
- Sep 1, 2006
- Review
- 16 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010641 (2001). 11 ancestors in all, the oldest K914350 (1991). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 4 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 3 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 2 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 1 generation backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- This deviceK062393 GE Vantage Pet Neuro SoftwareGE Healthcare · 2006
- Descendant · cites it directly · 2 of its ownK141074 Cortex ID SuiteGe Medical Systems, LLC · 2014
- Descendant · 2 generations on · 1 of its ownK231576 cNeuro cPETCombinostics OY · 2023
- Descendant · 3 generations on · 0 of its ownK261916 NeuroQuant PETCortechs Labs, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −4 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −3 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −2 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −1 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| 0 (this device) | K062393 | GE Vantage Pet Neuro Software | GE Healthcare | 2006 | — |
| +1 | K141074 | Cortex ID Suite | Ge Medical Systems, LLC | 2014 | — |
| +2 | K231576 | cNeuro cPET | Combinostics OY | 2023 | — |
| +3 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K041022 | Neuroq - Pet DPSummary page 1…al mean, relative to corresponding standard deviation. IdentificationofLegallyMarketed Equivalent Devices NeuroQ Syntermed, Inc. K041022 Scenium Mirada Solutions, Ltd. K042863 General Electric Company 53201… | 2004 |
| * | K042863 | SceniumSummary page 1…IdentificationofLegallyMarketed Equivalent Devices NeuroQ Syntermed, Inc. K041022 Scenium Mirada Solutions, Ltd. K042863 General Electric Company 53201 510(k) Summary… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141074 | Cortex ID Suite | 2014 | 2 |
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 5 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K141074 (Ge Medical Systems, LLC, 2014) has gone furthest, with 2 descendants 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.
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 Vantage software has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET and PET-CT brain scans. The software is deployed via Advantage Windows Workstation and PET-CT scanner console and is organized as a series of workf'lows steps, which are specific to use with particular drug and disease combination. The software aids in the assessment of human brain scans enabling automated analysis through…
Read the full statement (186 words)
The Vantage software has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET and PET-CT brain scans. The software is deployed via Advantage Windows Workstation and PET-CT scanner console and is organized as a series of workf'lows steps, which are specific to use with particular drug and disease combination.
The software aids in the assessment of human brain scans enabling automated analysis through quantification of the comparison of local peak activity values at standardized anatomical locations with the corresponding reference normal peak activity in age stratified control subjects. The resulting quantification is presented to the user through 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG metabolic activity between a subjects images and age stratified controls, which may be resulting from brain function alterations by neurodegenerative processes.
CT fusion to PET offers visualization of structural abnormalities, which may result from brain injury, trauma, disorder, disease or dysfunction, such as subdural hematorna, tumor, stroke (or cerebrovascutar disease) etc. Such tools may aid the physician in the rule out process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062393: GE Vantage Pet Neuro Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062393
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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