Cneuro cDAT

cNeuro cDAT enables visual evaluation and quantification of 123 Ioflupane (DaTSCAN) images. The software enables automated quantification of tracer uptake and comparison with the…

Registry build 21.09.26

cNeuro cDAT enables visual evaluation and quantification of 123 Ioflupane (DaTSCAN) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of 123 Ioflupane (DaTSCAN) images. cNeuro cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum. cNeuro cDAT has not been demonstrated to improve 123 Ioflupane reader performance for distinguishing positive from negative patients. cDAT is a module on the cNeuro Suite platform which provides common functionality and infrastructure. cNeuro Suite allows users to login to the system, to access and modify system data (organization, user and study data) and launch the medical device products of Combinostics (cNeuro cMRI, cNeuro cDSI, cNeuro cPET, and cNeuro cDAT). These end user applications share common functionality and infrastructure such as user authentication, study management and selection, study data storage, etc. The common functionality is provided by cNeuro Suite component. There is also a need to facilitate data transfers with hospital information systems on customers’ premises. These are implemented within a stand-alone data transfer utility component called cNeuro Gateway, which connects with cNeuro Suite.

16manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LLZ
Manufacturer City Province Registered as Device types
Shantou Institute OF Ultrasonic Instruments Co., Ltd. Shantou Guangdong Contract manufacturer 8
iRay Imaging Technology (Haining) Limited Haining Zhejiang Contract manufacturer 6
Chison Medical Technologies Co., Ltd. Wuxi Jiangsu Contract manufacturer 5
Coretronic Projection (Kunshan) Corporation Kunshan Jiangsu Contract manufacturer 3
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Siemens Shanghai, Medical Equipment Ltd. Shanghai Shanghai Contract manufacturer 10
Carestream Health, Inc., Global R&D Center Shanghai Shanghai Specification developer 8
Beijing Infervision Healthcare Medical Technology Co., Ltd. Beijing Beijing Complaint-file establishment 4

Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological

Record

Regulatory record for cNeuro cDAT
Listed by Combinostics, Finland
FDA product code LLZ
Device type System, Image Processing, Radiological
Device class Class 2
Regulation 21 CFR 892.2050
Establishment Manufacturer
510(k) K233908
Record published 2025-02-25

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only

Catalogue Numbers

Catalogue numbers for cNeuro cDAT
Catalogue number Size Status
1.0.x In distribution
2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Imagegrid Radiology Viewer System Candelis, Inc. 173
Tims System Foresight Imaging, LLC 159
System, Image Processing, Radiological Biomet Microfixation 146
RamSoft Ramsoft, Inc. 65
Joints Medstrat 62
OrthoView Meridian Technique Ltd 54
IPS KLS-Martin L.P. 48
NovaPACS Novarad Corp. 42
PointCloud Knee Instruments Unik Orthopedics, Inc 34
DTX Studio™ Clinic Nobel Biocare AB 34
Eaglesoft Patterson Technology Center 33
Medtronic Navigation Medtronic Navigation, Inc. 26

Showing 12 of 1,109. All products under System, Image Processing, Radiological

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K233908 2024-07-01
K171328 2018-01-08

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