Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K233908
    Device Name
    cNeuro cDAT
    Manufacturer
    Combinostics Oy
    Date Cleared
    2024-07-01

    (202 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Combinostics Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 ioflupane I 123 (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 ioflupane I 123 (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 ioflupane I 123 reader performance for distinguishing positive from negative patients. This device should not be used to deviate from ioflupane I 123 dosing and administration instructions. Refer also to ioflupane I 123 prescribing information for instructions.
    Device Description
    cNeuro™ cDAT is Software as a Medical Device (SaMD) intended to aid physicians in the evaluation of the loss of functional dopaminergic neuron terminals in the striatum through the quantification of ioflupane I 123 (DaTscan™) images. cNeuro™ cDAT is a fully automated image analysis software tool that provides tools for viewing DaTscan™ images and quantification of tracer uptake in the striatum with comparison to reference data from healthy controls. The results are summarized in a PDF-report. cNeuro™ cDAT quantifies DaTscan™ brain images and computes Striatal Binding Ratios (SBRs) for different volumes of interest (VOIs). SBRs are computed by subtracting the uptake in a background VOI from the tracer uptake in the target VOI and then dividing this value with uptake in a background VOI. Results are compared with normative values in a reference database and z-scores are presented. cNeuro™ cDAT quantifies the data by registering the images to a template where VOIs are defined. Quantification results are summarized in PDF-reports that are sent to the organization's PACS. cNeuro™ cDAT also offers interactive review of the DaTscan™ images and the quantification results in a browser-based viewer.
    Ask a Question
    K Number
    K231576
    Device Name
    cNeuro cPET
    Manufacturer
    Combinostics Oy
    Date Cleared
    2023-09-14

    (106 days)

    Product Code
    KPS, LLZ
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Combinostics Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 relative changes in PET-FDG glucose metabolism. cNeuro cPET additionally allows the user to generate information 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.
    Device Description
    cNeuro cPET has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET scans. The software enables the display, co-registration, and fusion of PET images with those from MRI. Additionally, cPET enables automated quantitative and statistical analysis of tracer uptake by registration of a volume-of-interest atlas to the PET images and by comparing voxel and region-based uptake with corresponding uptake in healthy, amyloid-negative subjects. There are two quantification pipelines, one when the patient's MRI is not available (PET-only) and one when the patient's MRI is available (PET-MR). Quantification results are presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain.
    Ask a Question
    K Number
    K171328
    Device Name
    cNeuro cMRI
    Manufacturer
    Combinostics Oy
    Date Cleared
    2018-01-08

    (248 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Combinostics Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    cNeuro cMRI is intended for automatic labeling, quantification of segmentable brain structures from a set of MR images. The software is intended to automate the current manual process of identifying, labeling and quantifying the segmentable brain structures identified on MR images. The intended user profile covers medical professionals who work with medical imaging. The intended operational environment is an office-like environment with a computer.
    Device Description
    cNeuro cMRI is intended for automatic labeling, quantification of segmentable brain structures from a set of MR images. The software is intended to automate the current manual process of identifying, labeling and quantifying the segmentable brain structures identified on MR images. As input, cNeuro cMRI uses T1-weighted (T1) and fluid-attenuated inversion recovery (FLAIR) DICOM MR images from a single time point. The T1 image is mandatory but the FLAIR image is optional. The user selects images through connection with a Picture Archiving and Communication System (PACS) or by selecting DICOM files from a folder. cNeuro cMRI displays the selected images together with information extracted from the DICOM headers. lmage processing starts with a pre-processing stage with bias-field correction and brain extraction before the actual segmentation and calculation of MRI biomarkers begins. When the processing has completed, the user can review the images with brain segmentations displayed as an overlay. cNeuro cMRI presents computed biomarkers corresponding to volumes of structures and FLAIR white matter hyperintensities. The computed biomarkers are corrected for the subject's head size, gender and age and are compared to corresponding biomarkers from a healthy reference population using a statistical model.
    Ask a Question

    Page 1 of 1