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510(k) Data Aggregation

    K Number
    K241982
    Device Name
    DeepFoqus (DeepFoqus-Accelerate)
    Date Cleared
    2025-04-04

    (273 days)

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

    Foqus Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DeepFoqus-Accelerate 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 reconstruction of non-contrast enhanced MRI images acquired with 1.5T or 3T Siemens and GE scanners using Sagittal, Axial, or Coronal T1, T2, or FLAIR sequences. DeepFoqus-Accelerate is intended to be used on adult scans only and not intended for use on mobile devices.
    Device Description
    DeepFoqus-Accelerate is an AI-powered MRI software that accepts up to 4x accelerated scans and reconstructs them to yield acceptable scans when compared to standard unaccelerated scans. DeepFoqus allows input of HDF5 and DICOM files, acquired with common MRI machines, containing accelerated T1, T2, and FLAIR image sets. Once inputted, DeepFoqus performs a series of reconstruction steps to produce clinical-quality scans from the undersampled data in the phase encoding direction. The full pipeline involves the following steps: 1. Ingestion of MRI scans as k-space and DICOM files. 2. Preprocessing steps to ensure that the input is in a standard format and meets acquisition requirements. 3. Processing through a pipeline that combines a collection of machine learning and signal processing modules that ensures that an appropriate range of fine-tuned models is applied to reconstruct a final volume. 4. Post-processing steps which include adjustments for windowing and image size. 5. Conversion of the final volume to DICOM format. The software provides a workflow for an MRI/Radiology Technologist to: 1. Input undersampled data into the software through a user interface 2. Start a processing pipeline and observe progress 3. Export reconstructed data for use in downstream applications
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