NeuroQ

NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified…

Registry build 21.09.26

NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare 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. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

4manufacturers in China registered for this device type
11catalogue numbers in this listing
13510(k) clearances naming this product code

Who Else Makes It

Concentrated in Beijing (1), Shanghai (1), Guangdong (1).

Chinese manufacturers registered for FDA product code KPS
Manufacturer City Province Registered as Device types
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Siemens Shenzhen Magnetic Resonance Ltd. Shenzhen Guangdong Contract manufacturer 8
Neusoft Positron Medical Systems Co., Ltd. Shen Yang Liaoning Manufacturer 1

Record

Regulatory record for NeuroQ
Listed by Syntermed, Inc., United States
FDA product code KPS
Device type System, Tomography, Computed, Emission
Device class Class 2
Regulation 21 CFR 892.1200
Establishment Specification developer, Repacker / relabeller, Manufacturer
510(k) K130451
Record published 2020-11-12
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only

Catalogue Numbers

Catalogue numbers for NeuroQ
Catalogue number Size Status
3.8 In distribution
3.6.20131127 In distribution
4.0.9995-r20250516 In distribution
4.0.991.r11 In distribution
4.0.9993.r20250312 In distribution
3.80.20210429.143255 In distribution
4.1.0036-r20250714 In distribution
4.1.0060-r20260515 In distribution
3.80.20210429.143255 In distribution
4.1.0060-r20260116 In distribution
3.75.20171019 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Emory Cardiac Toolbox Syntermed, Inc. 10
Discovery GE Medical Systems, L.L.C. 7
uMI Shanghai United Imaging Healthcare Co., Ltd. 7
Brightonix Brightonix Imaging Inc. 6
UltraSPECT Ultraspect USA, LLC 5
Discovery G E Medical Systems Israel Ltd. 5
Veriton CT Spectrum Dynamics Medical Ltd. 5
Cardius 2 Digirad Corp. 4
Encompass™ SRS Fibreplast™ System Qfix 4
Veriton NM Spectrum Dynamics Medical Ltd. 3
Cedars-Sinai Cardiac Suite Cedars Sinai Medical Center 3
Affinity Hermes Medical Solutions, AB 3

Showing 12 of 172. All products under System, Tomography, Computed, Emission

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K223422 2023-03-30
K180077 2018-08-16
K130902 2013-06-14
K130451 2013-05-17
K123646 2013-02-22
K072307 2008-03-14
K071503 2007-07-26
K042258 2004-10-04
K041022 2004-06-17
K040141 2004-01-30
K020300 2002-04-23
K014033 2002-02-22
K001276 2000-07-17

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer