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510(k) Data Aggregation

    K Number
    K230854
    Device Name
    SwiftMR
    Manufacturer
    AIRS Medical Inc.
    Date Cleared
    2023-10-27

    (213 days)

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

    AIRS Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of all body parts MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for MR images. SwiftMR is not intended for use on mobile devices.
    Device Description
    SwiftMR, is software used as a Medical Device (SaMD) consisting of a software algorithm that enhances images taken by MRI scanners. The device only processes DICOM images for the end User and is intended to be used by radiology technologists in an imaging center, clinic, or hospital. The device's inputs are MRI images in DICOM format. The deep learning algorithm produces enhanced images as outputs with reduced noise and increased sharpness in DICOM format. The deep learning algorithm performs noise reduction with the ability of adjusting the denoising level 0 to level 8, and sharpening filter performs the sharpening function with the ability of adjusting the sharpness level from level 0 to level 5. SwiftMR provides an automatic image quality enhancement function for MR images acquired in various environments. SwiftMR can only be used for professional purposes and is not intended for use on mobile devices.
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    K Number
    K220416
    Device Name
    SwiftMR
    Manufacturer
    AIRS Medical Inc.
    Date Cleared
    2022-05-25

    (100 days)

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

    AIRS Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of brain. spine, knee, ankle, shoulder and hip MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for non-contrast enhanced MR images. SwiftMR is not intended for use on mobile devices.
    Device Description
    SwiftMR, is software used as a Medical Device (SaMD) consisting of a software algorithm that enhances images taken by MRI scanners. The device only processes DICOM images for the end User and is intended to be used by radiology technologists in an imaging center, clinic, or hospital. The device's inputs are standard of care MRI images in DICOM format. The deep learning algorithm produces enhanced images as outputs with reduced noise and increased sharpness in DICOM format. The deep learning algorithm performs the denoising function and sharpening filter performs the sharpening function with the ability of adjusting the sharpness level from level 0 to level 5. SwiftMR provides an automatic image quality enhancement function for MR images acquired in various environments. SwiftMR can only be used for professional purposes and is not intended for use on mobile devices. SwiftMR 's automation procedure is as follows: - . Receive MR images that are in DICOM format - . Image quality enhancement using Deep Learning model and sharpening filter - Transfer enhanced MR image as DICOM format to PACS . There are four deep learning algorithms: three are for the general pulse sequences and the other one is for the TOF pulse sequences. The four deep learning algorithms share the same network architecture, input and label data generation method, training procedures. The only difference between the four deep learning algorithms is the input / label dataset used for training. After integration with the facilities PACS, SwiftMR performs image processing in the background automatically. At the same time, SwiftMR allows logged-in users to use its functions and view the processing status. When loqged in as the System Admin, the function is available to the control automation procedure and system change settings. On the User side, the User can retrieve the results of image processing in the form of a worklist by login to the user account. The software provides three main functions, which are image processing, quality check and progress monitoring. The software is intended to run automatically in the background so that it does not interrupt the workflow of users. When the user executes MR scans as he/she usually does, the newly acquired images are automatically uploaded to the server and registered in the database (DB) for image processing. Once image processing is complete, the images are sent to PACS. If the user wishes to monitor this automated workflow to check on the status of image processing, he/she can check the main page of the client application or toast messages will appear on the bottom right corner upon completion of each processing. After using the software, they should log out for security reasons. A settings menu is provided in the form of a user interface to enable system admin to modify software settings as required by the institution or respective user.
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    K Number
    K210999
    Device Name
    SwiftMR
    Manufacturer
    AIRS Medical Inc.
    Date Cleared
    2021-10-14

    (195 days)

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

    AIRS Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of brain MRI images in DICOM format. It can be used for noise reduction and increasing image sharpness for non-contrast enhanced MRI images. SwiftMR is not intended for use on mobile devices.
    Device Description
    SwiftMR, is software used as a Medical Device (SaMD) consisting of a software algorithm that enhances images taken by MRI scanners. The device only processes DICOM images for the end User and is intended to be used by radiology technologists in an imaging center, clinic, or hospital. The device's inputs are standard of care MRI images in DICOM format. The deep learning algorithm produces enhanced images as outputs with reduced noise and increased sharpness in DICOM format. The device applies both denoising and sharpness increase functions simultaneously. SwiftMR provides an automatic image quality enhancement function for MR images acquired in various environments. SwiftMR can only be used for professional purposes and is not intended for use on mobile devices. SwiftMR 's automation procedure is as follows: - . Upload MR images that have been taken or converted to the DICOM format - . Image quality enhancement using Deep Learning model - . Download enhanced MR image as DICOM format There are two deep learning algorithms that should be selected by users according to the pulse sequences. One is for the general pulse sequences and the other is for the TOF pulse sequences. The two deep learning algorithms share network architecture, input data generation method, training procedures. The only difference between the two deep learning algorithms is the input / label dataset used for training. After integration with the facilities PACS, SwiftMR performs image processing in the background automatically. At the same time, SwiftMR allows logged-in users to use its functions and change product settings through the client application. When logged in as the System Admin, the function is available to the control automation procedure and system change settings. On the User side, the User can retrieve the results of image processing in the form of a worklist by login to the user account. The software provides three main functions, which are image processing, quality check and progress monitoring. The software is intended to run automatically in the background so that it does not interrupt the workflow of users. When the user executes MR scans and saves the images in PACS as he/she usually does, the newly acquired images are automatically uploaded to the server and registered in the database (DB) for image processing. Once image processing is complete, the images are sent back to PACS. If the user wishes to monitor this automated workflow to check on the status of image processing, he/she can log in to the Client App, and notifications will be received upon each task completion. Detailed information is also available when the main worklist is opened, and MR Study and/or Series in concern is selected. A settings menu is provided in the form of a user interface to enable users and system admin to modify software settings as required by the institution or respective user.
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