FDA.reportPublic FDA data

COMBINOSTICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30144705273014470527COMBINOSTICS1N2026-01-01Hatanpaan Valtatie 24 Tampere Pirkanmaa FI 33100

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
06430070841021cNeuro cMRI - https://www.combinostics.com/cmri/+358400139013contact@combinostics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2177511419377590K233908cNeuro cDATLLZ2024-07-01
2177511466664444K231576cNeuro cPETKPS2023-09-14
2177511348186474K171328cNeuro cMRILLZ2018-01-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ22024-07-01
KPS12023-09-14

PMN#

GUDID#

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 thecorresponding tracer uptake in healthy subjects as provided by normal population databasesof 123 Ioflupane (DaTSCAN) images. cNeuro cDAT assists in detection of loss of functionaldopaminergic neuron terminals in the striatum. cNeuro cDAT has not been demonstrated toimprove 123 Ioflupane reader performance for distinguishing positive from negative patients.cDAT is a module on the cNeuro Suite platform which provides common functionality andinfrastructure. cNeuro Suite allows users to login to the system, to access and modify systemdata (organization, user and study data) and launch the medical device products ofCombinostics (cNeuro cMRI, cNeuro cDSI, cNeuro cPET, and cNeuro cDAT). These end userapplications share common functionality and infrastructure such as user authentication, studymanagement and selection, study data storage, etc. The common functionality is provided bycNeuro Suite component. There is also a need to facilitate data transfers with hospitalinformation systems on customers’ premises. These are implemented within a stand-alonedata transfer utility component called cNeuro Gateway, which connects with cNeuro Suite.

Combinostics Oy

2026-05-06

cNeuro cDAT - cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data.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, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB).cNeuro cDAT has not been demonstrated to improve 123 ioflupane reader performance for distinguishing positive from negative patients. This device should not be used to deviate from 123 ioflupane dosing and administration instructions. Refer also to 123 ioflupane prescribing information for instructions.

Combinostics Oy

2025-02-25

cNeuro cPET - cNeuro cPET aids physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans.The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest and voxel-based maps of the brain. cNeuro cPET allows the user to generate information regarding relative changes in PET-FDG glucose metabolism.cNeuro cPET additionally allows the user to generate information regarding relative changes in PET brain amyloid load between a subject’s images and a normal database, which may be the result of brain neurodegeneration.PET co-registration and fusion display capabilities with MRI allow PET findings to be related to brain anatomy.cNeuro cPET aids physicians in the image interpretation of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline.

Combinostics Oy

2025-02-24