# K180077: NeuroQ 3.8

- Pathway: 510(k) (Traditional)
- Applicant: Syntermed
- Decided: Aug 16, 2018 after 218 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: 10 generations back to K010641 (2001). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041022: Neuroq - Pet DP, Syntermed, Inc. (2004) Summary page 6.
- K072307: Quantitative Neuroq 3.0, Syntermed, Inc. (2008) Summary page 6.
- K130451: Neuroq 3.6, Syntermed, Inc. (2013) Summary page 4.
- K121278: Hermes Medical Imaging Suite V5.2, Hermes Medical Solutions AB (2012) Summary page 4.
- K153355: Xeleris 4.0 Processing and Review Workstation, GE Healthcare (2016) Summary page 4.

## Indications for use
The NeuroQ™ 3.8 program is used to regionally quantify activity in brain PET and SPECT scans using a ROI count method. It displays co-registered PET, SPECT and CT images, along with output from quantification of activities reflecting regional concentrations of FDG, amyloid imaging agents, SPECT perfusion and dopamine transporter radiotracers, relative to activities in any of several user-selected reference regions or whole brain. It provides for displaying and quantifying the regional differences between two PET or SPECT brain studies for the same patient, or the levels of amyloid imaging agents retained in specified brain regions of a patient, and for assisting the user in the examination of brain scans acquired for assessing neurodegenerative processes underlying symptoms of cognitive and movement disorders by comparing regional activity values to each other and to those in brain scans acquired for asymptomatic control subjects. These neurodegenerative processes can be Alzheimer’s disease, Lewy body dementia, Parkinson’s disease with dementia, vascular dementia, and frontotemporal dementia. 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/K180077
Methodology: https://510kreport.com/methodology