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510(k) Data Aggregation

    K Number
    K242292
    Device Name
    uAI Easy Triage ICH
    Manufacturer
    Shanghai United Imaging Intelligence Co., Ltd.
    Date Cleared
    2024-09-24

    (53 days)

    Product Code
    QAS
    Regulation Number
    892.2080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai United Imaging Intelligence Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    uAl Easy Triage ICH is a radiological computer-assisted triage and notification software device indicated for analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected positive findings of Intracranial Hemorrhage (ICH).
    Device Description
    uAI Easy Triage ICH is a radiological computer-assisted triage and notification software intended to assist radiologists by flagging potential intracranial hemorrhage (ICH) in non-contrast head CT images. The Triage Software is a component of the uAI Easy Triage platform, a comprehensive medical imaging communication system designed to integrate and deploy specialized image processing applications. The uAI Easy Triage ICH algorithm uses artificial intelligence CNN (convolutional neural networks) and advanced image processing to triage the non-contrast CT images for suspicious intracranial hemorrhage. The uAI Easy Triage ICH alerts users to new studies with suspicious ICH findings via pop-up notifications. The software provides both active and passive notification mechanisms. Active notifications are presented as an alert icon with a count of pending cases, and an alert status bar displaying patient details, suspected findings, and the time of examination. Passive notifications are represented by an icon beside the patient's name in the list for cases with detected ICH findings. Additionally, the application offers a DICOM image preview feature for radiologists to review. This preview is strictly informational, devoid of diagnostic markers, and is not to be used for definitive diagnosis. The uAI Easy Triage ICH embodies the core algorithmic technology that identifies image characteristics consistent with intracranial hemorrhage. The application reads DICOM files, verifies their compatibility with the prescribed acquisition protocols, executes the triage algorithm, and communicates findings in DICOM format, compatible with the uAI Easy Triage Platform.
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    K Number
    K240411
    Device Name
    uAI Portal
    Manufacturer
    Shanghai United Imaging Intelligence Co., Ltd.
    Date Cleared
    2024-09-06

    (207 days)

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

    Shanghai United Imaging Intelligence Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    uAI Portal is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation of examinations within healthcare institutions. It has the following additional indications: The Lower Extremity Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating CTA images of lower extremities. The Head and Neck Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with head and neck CTA. The Coronary Analysis is intended to provide a tool for viewing, manipulating imaging datasets acquired with CCTA. The Pulmonary Artery Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with CTPA. The Aorta Analysis is intended to provide a tool for viewing, and evaluating imaging datasets acquired with aorta CTA.
    Device Description
    uAI Portal is a comprehensive software solution designed to process, review and analyze CT studies. It can transfer images in DICOM 3.0 format over a medical imaging network or local file system. These images can be functional data, as well as anatomical datasets. It can be at one or more time-points or include one or more time-frames. Multiple display formats including VR, MIP, MPR, Probe, CPR, and SCPR. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice. uAI Portal contains the following applications: - The Lower Extremity Vessel Analysis - . The Head and Neck Vessel Analysis - . The Coronary Analysis - . The Pulmonary Artery Analysis - . The Aorta Analysis
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    K Number
    K222755
    Device Name
    uMR 680
    Manufacturer
    Shanghai United Imaging Intelligence Co., Ltd.
    Date Cleared
    2023-02-16

    (157 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai United Imaging Intelligence Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The uMR 680 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
    Device Description
    The uMR 680 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 680 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
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    K Number
    K193271
    Device Name
    uAI EasyTriage-Rib
    Manufacturer
    Shanghai United Imaging Intelligence Co., Ltd.
    Date Cleared
    2021-01-15

    (416 days)

    Product Code
    QFM
    Regulation Number
    892.2080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai United Imaging Intelligence Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    uAl EasyTriage-Rib is a radiological computer-assisted triage and notification software device for analysis of CT chest images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing trauma studies with suspected positive findings of multiple (3 or more) acute rib fractures.
    Device Description
    uAl EasyTriage-Rib is a radiological computer-assisted triage and notification software device indicated for analysis of CT chest images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected positive findings of multiple (3 or more) acute rib fractures. The device consists of the following two modules: (1) uAl EasyTriage-Rib Server; and (2) uAl EasyTriage-Rib Studylist Application that provides the user interface in which notifications from the application are received.
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