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510(k) Data Aggregation

    K Number
    K243769
    Device Name
    QFR (3.0)
    Manufacturer
    QFR Solutions bv
    Date Cleared
    2025-04-04

    (119 days)

    Product Code
    QHA
    Regulation Number
    892.1600
    Why did this record match?
    Product Code :

    QHA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QFR is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by QFR are used in a clinical setting on X-ray images of an individual patient. The results are only intended for use by the responsible clinicians.
    Device Description
    QFR is delivered as a standalone software package which is installed and running on a server system in the server room of the cathlab or the hospital. The server offers all functionalities that are required to work with the quantitative measurement in X-ray Angiographic (XA) patient studies supported by the QFR device. QFR will be used by interventional cardiologists and researchers to obtain quantifications of lesions in coronary vessels. QFR has been developed as a web-based application to run in a web browser in the control room of the cathlab or in a hospital image review room. The import of images and the export of analysis results are via PACS. The QFR device calculates the QFR value based on an anatomical model which is the result of a 3D reconstruction using the 2D contours obtained from two angiographic projections with angles >=25 degrees apart. These projections are acquired through monoplane or biplane XA systems. The algorithm involves three key steps: (1) Vessel Selection, (2) Contours Detection, and (3) QFR Analysis: 1. Vessel Selection: Angiograms are pre-classified by a deep learning model, identifying main epicardial vessels such as RCA, LAD, and LCx. The user then chooses the segment for analysis, and the software automatically selects end-diastolic image frames. The end-diastolic frame is determined as the angiogram frame with the vessel lumen adequately filled with contrast in both image sequences. This selection is either based on the patient's electrocardiogram when available or performed by the software using a deep learning model. It is essential for the user to verify this selection before proceeding with the analysis. The chosen end-diastolic frame serves as the projection view for the subsequent 3D reconstruction of the vessel. 2. Contours Detection. First, the system runs another deep learning model for coronary vessel segmentation as input to identify anatomical corresponding points on both projections for automatic correction of the system distortions introduced by the isocenter offset and the respiration-induced heart motion. Second, begins the automatic detection of start and end positions of the vessel segment to be reconstructed on the projection views, and extract its contours and centerline. Third, the position of the start and end point must be confirmed by the user. 3. QFR Analysis: The QFR value is computed from the arterial and reference diameter function calculated from the 3D reconstruction based on the contours detected on the cross-sections of the vessel segment, and the patient-specific volumetric flow rate calculated from the automated TIMI frame count. The reference diameter and bifurcations are used to determine the flow distribution at coronary bifurcations and calculate the reference diameter function. The reconstructed 3D model is used to calculate the QFR value. A report is generated by QFR that shows patient information, image acquisition information (both obtained from the DICOM input), analysis results (vessel sizing and QFR value) and snapshot images showing the vessel boundaries.
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    K Number
    K232147
    Device Name
    CAAS Workstation
    Manufacturer
    Pie Medical Imaging B.V.
    Date Cleared
    2024-04-09

    (265 days)

    Product Code
    QHA, LLZ
    Regulation Number
    892.1600
    Why did this record match?
    Product Code :

    QHA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CAAS Workstation features segmentation of cardiovascular structures, 3D reconstruction of vessel segments and catheter path based on multiple angiographic images, measurement and reporting tools to facilitate the following use: - Calculate the dimensions of cardiovascular structures; - Quantify stenosis in coronary vessels; - Determine C-arm position for optimal imaging of cardiovascular structures; - Quantify pressure drop in coronary vessels; - Enhance stent visualization and measure stent dimensions; CAAS Workstation is intended to be used by or under supervision of a cardiologist.
    Device Description
    CAAS Workstation is an image post-processing software package for advanced visualization and ysis in the field of cardiology or radiology and offers functionality to view X-Ray angiographic images, to segment cardiovascular structures in these images, to analyze and quantify these cardiovascular structures and to present the results in different formats. CAAS Workstation is a client-server solution intended for usage in a network environment or standalone usage and runs on a PC with a Windows operating system. It can read DICOM X-ray images from a directory, or receive DICOM images from the X-ray or PACS system. CAAS Workstation is composed out of the following analysis workflows: StentEnhancer and vFFR for calculating dimensions of coronary vessels, quantification of stenosis and calculating the pressure drop and vFFR value based on two 2D X-Ray angiographic images. Semi-automatic contour detection forms the basis for the analyses. Results can be displayed on the screen, printed or saved in a variety of formats to hard disk, network, PACS system or CD. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats. The functionality is independent of the type of vendor acquisition equipment.
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    K Number
    K210093
    Device Name
    AccuFFRangio
    Manufacturer
    ArteryFlow Technology Co., Ltd.
    Date Cleared
    2021-09-10

    (239 days)

    Product Code
    QHA, LLZ
    Regulation Number
    892.1600
    Why did this record match?
    Product Code :

    QHA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AccuFFRangio is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by AccuFFRangio are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.
    Device Description
    ArteryFlow® AccuFFRangio is designed as a stand-alone software package to run on a PC. This software can read traditional x-ray angiographic images with DICOM format from the local file directory. The AccuFFRangio is composed of the following analysis workflows: Image Loading, Frame Selection, Vessel Reconstruction, QCA Vessel Quantification, and AccuFFRangio Calculation for visualization of the target coronary segment, quantification of the stenosis and pressure drop of the coronary seqment. The AccuFFRangio parameter is only for quantitative imaging output but not for diagnosis and the AccuFFRanigo product has a moderate level of concern. The user can calculate the pressure drop and AccuFFRangio (FFR) value for the coronary vessel. To obtain these values for a specific lesion in a coronary vessel, the user has to start with Frame Selection using two angiographic images from different views. In each of these images, a classic 2D coronary contour detection is performed, after which a reconstruction of the coronary segment is obtained in 3D space. Based on the 3D reconstruction and user input of the aortic pressure, the pressure drop and AccuFFRangio value can be calculated. AccuFFRangio enables interventional cardiologists to obtain accurate anatomical quantifications of one or more lesions in the analyzed coronary segment, and to assess the best viewing angles which can be helpful for optimal visualization of the lesion during percutaneous coronary intervention (PCI) treatment. Results can be displayed and generated by the software, which contains patient information, imaging of actual and reference vessel boundaries, dimensions of the vessel sizing, pressure drop, and AccuFFRangio value. The results can be export in PDF format. This functionality is independent of the type of vendor acquisition equipment.
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    K Number
    K182611
    Device Name
    Qangio XA 3D
    Manufacturer
    Medis Medical Imaging Systems bv
    Date Cleared
    2019-05-30

    (251 days)

    Product Code
    QHA, LLZ
    Regulation Number
    892.1600
    Why did this record match?
    Product Code :

    QHA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QANGIO XA 3D is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by QANGIO XA 3D are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.
    Device Description
    QANGIO XA 3D is the Medis software solution for the quantitative analysis of cardiac X-ray Angiography (XA) studies. QANGIO XA 3D features: - Acquisition guide and series selection guide - Annotations and basic measurements - 2D and 3D OCA vessel detection - 2D and 3D OCA vessel quantification - QFR calculations: Quantitative Flow Ratio (QFR) analysis with fixed flow model (fQFR) and contrast flow models (cQFR). - Single vessel report QANGIO XA 3D will be used by interventional cardiologists and researchers to obtain quantifications of lesions in coronary vessels, to determine the functional significance of the individual or consecutive multiple lesions, prior, during or after percutaneous coronary intervention treatment. QANGIO XA 3D has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment.
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