Device
cNeuro cDAT enables visual evaluation and quantification of 123 Ioflupane (DaTSCAN) images.
Manufacturer
Combinostics Oy
Combinostics Oy
Model: 2
DI: 06430070845029
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1589cafa-b968-4e53-b45c-6adedd911f3a
Distribution Status:
In Commercial Distribution
DUNS Number:
368347547
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06430070845029
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 57812
Name: Radiology DICOM image processing application software
Definition:
A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
FDA Product Codes
LLZ
System, Image Processing, Radiological