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510(k) Data Aggregation

    K Number
    K242683
    Device Name
    QP-Prostate® CAD
    Manufacturer
    Quibim S.L.
    Date Cleared
    2025-03-18

    (193 days)

    Product Code
    QDQ, ODO
    Regulation Number
    892.2090
    Why did this record match?
    Applicant Name (Manufacturer) :

    Quibim S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QP-Prostate® CAD is a Computed Aided Detection and Diagnosis (CADe/CADx) image processing software that automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI. The software is intended to be used as a concurrent read by physicians with proper training in a clinical setting as an aid for interpreting prostate MRI studies. The results can be displayed in a variety of DICOM outputs, including identified suspected lesions marked as an overlay onto source MR images. The output can be displayed on third-party DICOM workstations and Picture Archive and Communication Systems (PACS). Patient management decisions should not be based solely on the results of QP-Prostate® CAD.
    Device Description
    QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CADe/CADx) image processing software. QP-Prostate® CAD uses Al-based algorithms trained with pathology data to detect suspicious lesions for clinically significant prostate cancer. The device automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI and provides marks over regions of the images that may contain suspected lesions. There are two possible markers that are provided in different colors suggesting different levels of suspicion of clinically significant prostate cancer (moderate or high suspicion level). The software is intended to be used as a concurrent read by physicians with proper training in a clinical setting as an aid for interpreting prostate MRI studies. The results can be displayed in a variety of DICOM outputs, including identified suspected lesions marked as an overlay onto source MR images. The output can be displayed on third-party DICOM workstations and Picture Archive and Communication Systems (PACS). Based on biparametric input consisting of T2W and DWI series, the analysis is run automatically, and the output in standard DICOM formats is returned to PACS.
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    K Number
    K232231
    Device Name
    QP-Brain®
    Manufacturer
    Quibim S.L.
    Date Cleared
    2023-12-13

    (139 days)

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

    Quibim S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QP-Brain® is a medical imaging processing application intended for automatic labeling and volumetric quantification of segmentable brain structures and white matter hyperintensities (WMH) from a set of adults and adolescents 18 and older MR images. Volumetric measurements may be compared to reference percentile data. The application with proper training, as a support tool in assessment of structural MRIs. Patient management decisions should not be results of the device.
    Device Description
    QP-Brain® is a medical image processing and analyzing software intended for image processing to analyze brain MR imaging studies. These brain MR images, when interpreted by clinicians with proper training, may yield clinically useful information. QP-Brain® is an automated MR imaging post-processing medical device software that uses 3D T1-weighted (T1w) Gradient Echo structural MRI scans to provide a quantitative imaging analysis and automatic segmentation of brain regions. If T2 FLAIR images are uploaded. QP-Brain® uses this sequence to automatically identify white matter hyperintensities using Artificial Intelligence. Once the T1 MR or T2 FLAIR has been uploaded, QP-Brain® will check the available sequences for compatibility before automatically launching the analysis. The output of the medical device consists of specific volumes with seqmentation overlay as well as different reports with quantitative information. The outputs can be returned to and displayed on third-party DICOM workstations and Picture Archive and Communication Systems (PACS). In case age and gender information is available on the study DICOM tags for brain structure analysis module, all quantified volumes are framed in a normative database to be compared with cognitively normal adults of the same age and gender. QP-Brain® also allows for longitudinal information reporting if a patient has acquired more than one MRI over time.
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    K Number
    K203582
    Device Name
    QUIBIM Precision Prostate (qp-Prostate)
    Manufacturer
    QUIBIM S.L.
    Date Cleared
    2021-02-04

    (59 days)

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

    QUIBIM S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    qp-Prostate is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of qp-Prostate. qp-Prostate does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data.
    Device Description
    qp-Prostate is a medical image viewing, processing and analyzing software package for use by a trained user or healthcare professional, including radiologists specialized in prostate imaging, urologists and oncologists. These prostate MR images, when interpreted by a trained physician, may yield clinically useful information. qp-Prostate consists of a modular platform based on a plug-in software architecture. Apparent Diffusion Coefficient (ADC) post-processing and Perfusion - Pharmacokinetics post-processing (PKM) are embedded into the platform as plug-ins to allow prostate imaging quantitative analysis. The platform runs as a client-server model that requires a high-performance computer installed by QUIBIM inside the hospital or medical clinic network. The server communicates with the Picture Archiving and Communication System (PACS) through DICOM protocol, qp-Prostate is accessible through the web browser (Google Chrome or Mozilla Firefox) of any standard "off-the-shelf" computer connected to the hospital/center network. The main features of the software are: 1. Query/Retrieve interaction with PACS; 2. Apparent Diffusion Coefficient (ADC) post-processing (MR imaging); 3. Perfusion Pharmacokinetics (PKM) post-processing (MR imaging); 4. DICOM viewer; and 5. Structured reporting. The software provides MR imaging analysis plug-ins to objectively measure different functional properties in prostate images.
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