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510(k) Data Aggregation

    K Number
    K203555
    Device Name
    AmCAD-UT
    Manufacturer
    AmCad BioMed Corporation
    Date Cleared
    2021-09-08

    (275 days)

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

    AmCad BioMed Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AmCAD-UT is a Windows-based computer-aided detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA-cleared ultrasound systems. The region of interest (ROI) of a user-selected thyroid nodule is defined by users or suggested by an AI contouring algorithm. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
    Device Description
    AmCAD-UT is a Windows-based computer-assisted detection (CADe) software application device designed to assist medical professionals in analyzing thyroid ultrasound images with the region of interest (ROI) of a selected nodule defined by users or suggested by an Al algorithm after the user specifies the location of the nodule. After the initial review of thyroid ultrasound images by the physician, he/she can use AmCAD-UT to analyze thyroid images for further interpretation. Once the ROI is confirmed, the physician may process the image for detection and quantification of sonographic characteristics (i.e., hyperechoic foci, echogenicity, texture, margin, orientation and anechoic areas) by AmCAD-UT. The device provides more detailed information with quantification and visualization of the sonographic characteristics of thyroid nodule that may assist physician in his/her complete interpretation. The software application automatically generates reports given the user preference inputs (e.g., the nodule size, nodule location and shape, and the presence or absence of the sonographic characteristics) annotated during the image analysis process. A report form has been designed by AmCad to be consistent with the conventional clinical thyroid report form. An output of the report may be viewed and sent to paper printers or saved on the standalone PC or review station as PDF file.
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    K Number
    K180867
    Device Name
    AmCAD-UO
    Manufacturer
    AmCad BioMed Corporation
    Date Cleared
    2018-12-28

    (270 days)

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

    AmCad BioMed Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AmCAD-UO is a PC-based, self-contained, non-invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA-cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician's evaluation and monitoring of the airway state.
    Device Description
    AmCAD-UO is a PC-based, self-contained, non-invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA-cleared ultrasound system. The software is designed to visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician's evaluation and monitoring of the airway state. The generated information by AmCAD-UO software device must not be used alone for primary diagnostic interpretation.
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    K Number
    K180006
    Device Name
    AmCAD-UT Detection 2.2
    Manufacturer
    AmCad BioMed Corporation
    Date Cleared
    2018-08-31

    (241 days)

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

    AmCad BioMed Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AmCAD-UT® Detection is a Windows-based computer-aided detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA-cleared ultrasound systems, with user-selected regions of interest (ROI). After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
    Device Description
    AmCAD-UT® Detection 2.2 is a Windows-based computer-assisted detection (CADe) software application device designed to assist medical professionals in analyzing thyroid ultrasound images of user selected regions of interest (ROI). After the initial review of thyroid ultrasound images by the physician, he/she can use AmCAD-UT Detection to analyze thyroid images for further interpretation. The physician selects an ROI to define the initial boundary of the ROI. Once the ROI is confirmed, the physician may process the image for detection and quantification of sonographic characteristics (i.e., hyperechoic foci, echogenicity, texture, margin, orientation and anechoic areas) by AmCAD-UT Detection. The device provides more detailed information with quantification and visualization of the sonographic characteristics of thyroid nodule that may assist physician in his/her complete interpretation. The software application automatically generates reports given the user preference inputs (e.g., the nodule size, nodule location and shape, and the presence or absence of the sonographic characteristics) annotated during the image analysis process. A report form has been designed by AmCad to be consistent with the conventional clinical thyroid report form. An output of the report may be viewed and sent to paper printers or saved on the standalone PC or review station as PDF file.
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    K Number
    K162574
    Device Name
    AmCAD-US
    Manufacturer
    AmCad BioMed Corporation
    Date Cleared
    2017-05-30

    (257 days)

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

    AmCad BioMed Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AmCAD-US is a software device intended to visualize the statistical distributions of backscattered signals echoed by tissue compositions in the body. The backscattered signals are subject to the RF or Envelope data made available by an FDA-cleared general-purpose ultrasound system. The US-mode images displayed on AmCAD-US must not be used alone for primary diagnostic interpretation.
    Device Description
    AmCAD-US (model number 1.0) is intended to visualize and analyze the statistical distributions of backscattered signals echoed by tissue compositions in the body. AmCAD-US, which uses the proprietary technology and algorithms, is a software package designed to quantify and visualize the backscattered statistics contained in ultrasound image data obtained from an FDA-cleared general purpose ultrasound system. The device provides dual mode images, including conventional B-mode ultrasound image in gray scale and color-mapped US (ultrasound structure) mode image. The US-mode provides a means for viewing and displaying the backscatter statistical values. The device uses parametric model or nonparametric statistics that best describes the distribution curve of the backscattered signals. The parameters vary by the US method (backscattered statistics) selected. The preferences include options to set the parameters mapped onto the image and US method options applied to the data. The user can also select a specific region of interest (ROI) on the image for quantification analysis. The histogram view of the data provides a different view to accommodate the variation between tissue and tissue states. AmCAD-US has a data export function to record and save the analysis results. Note that the US-mode images displayed on AmCAD-US must not be used alone for primary diagnostic interpretation.
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    K Number
    K170069
    Device Name
    AmCAD-UV
    Manufacturer
    AmCad BioMed Corporation
    Date Cleared
    2017-04-26

    (107 days)

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

    AmCad BioMed Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AmCAD-UV is a software device designed for classifying the ultrasonic color intensity data and allowing users to view classified color-coded signals, namely, primary pulsatile, and unidentified signals of flow Doppler ultrasound images. It is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not be used alone for primary diagnostic interpretation.
    Device Description
    AmCAD-UV (model number 1.0) is a software device designed for classifying the ultrasonic color intensity data and allowing users to view classified color-coded signals, namely, primary pulsatile, secondary pulsatile, and unidentified signals of flow Doppler ultrasound images. The ultrasonic color intensity data here means the flow Doppler ultrasound images (i.e. color and power Doppler ultrasound images) acquired from FDA-cleared ultrasound systems. The device quantifies those color pixels within the quadrilateral scanning area on a sequence of flow Doppler ultrasound images based on their color intensities and groups the color pixels with similar periodic pulsatile waveforms. The image with classified color-coded pulsatile signals will then be generated by the proposed device for users to evaluate the vascular pulsatility, such as pulsatile flow velocity and flow energy, dependent on the type of flow Doppler ultrasound image analyzed. As a PACS (Picture Archiving and Communication System) software device, AmCAD-UV does not generate new quantities but provide pulsatile information of existing information from flow Doppler ultrasound images. The device is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not be used alone for primary diagnostic interpretation. AmCAD-UV provides dual images for viewing original flow Doppler ultrasound images and the image with classified color-coded pulsatile signals. The user can delineate a specific region of interest (ROI) on the image for analysis. The device also provides a trend chart for displaying pulsatile waveforms with summarized statistics. The device can export the quantified values of the classified pulsatile signals in text format and export the sequence of color-coded pulsatile images and the waveform trend chart in Bitmap (*.bmp) and JPEG (*.jpg or *.jpeg) formats.
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