# K130451: Neuroq 3.6

- Pathway: 510(k) (Traditional)
- Applicant: Syntermed, Inc.
- Decided: May 17, 2013 after 84 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010641 (2001). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072307: Quantitative Neuroq 3.0, Syntermed, Inc. (2008) Summary page 1.
- K123528: Scenium, Siemens Medical Solutions USA, Inc. (2012) Summary page 1.
- K041022: Neuroq - Pet DP, Syntermed, Inc. (2004) Summary page 2.

## Most influential descendants
- K180077: NeuroQ 3.8 (2018), 0 descendants of its own

## Indications for use
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 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. 3) assist with comparisons of activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data 4) NeuroQ 3.6 provides added functionality to provide analysis of amyloid uptake levels in brain regions. The product is intended for use by trained nuclear technicians and nuclear medicine physicians. The clinician remains ultimately responsible for the final interpretation and diagnosis based on standard practices and visual interpretation of all SPECT and.PET data.

Source page: https://510kreport.com/device/K130451
Methodology: https://510kreport.com/methodology