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510(k) Data Aggregation

    K Number
    K202414
    Device Name
    BrainInsight
    Manufacturer
    Hyperfine Research, Inc
    Date Cleared
    2021-01-07

    (136 days)

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

    Hyperfine Research, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BrainInsight is intended for automatic labeling, spatial measurement, and volumetric quantification of brain structures from a set of low-field MR images and returns annotated images, color overlays, and reports.
    Device Description
    BrainInsight is a fully automated MR imaging post-processing medical software that image alignment, whole brain segmentation, ventricle segmentation, and midline shift measurements of brain structures from a set of MR images from patients aged 18 or older. The output annotated and segmented images are provided in a standard image format using segmented color overlays and reports that can be displayed on third-party workstations and FDA cleared Picture Archive and Communications Systems (PACS). The high throughput capability makes the software suitable for use in routine patient care as a support tool for clinicians ir assessment of low-field (64mT) structural MRIs. BrainInsight provides overlays and reports based on 64mT 3D MRI series of a T1 and T2-weighted sequence. The outputs of the software are DICOM images which include volumes that have been annotated with color overlays, with each color representing a particular segmented region, spatial measurement of anatomical structures, and information reports computed from the image data, segmentations, and measurements. The BrainInsight processing architecture includes a proprietary automated internal pipeline that performs whole brain segmentation, ventricle segmentation, and midline shift measurements based on machine learning tools. Additionally, the system's automated safety measures include automated quality control functions, such as tissue contrast check and scan protocol verification. The system is installed on a standard computing platform, e.g. server that may be in the cloud, and is designed to support file transfer for input and output of results.
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    K Number
    K201722
    Device Name
    Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
    Manufacturer
    Hyperfine Research, Inc.
    Date Cleared
    2020-08-11

    (49 days)

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

    Hyperfine Research, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Point-of-Care Magnetic Resonance Imaging Device is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
    Device Description
    The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging. It enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. The POC MRI system can generate MRI data sets with a broad range of contrasts. The user interface includes touch screen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery.
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    K Number
    K192002
    Device Name
    Lucy Point-of-Care Magnetic Resonance Imaging Device
    Manufacturer
    Hyperfine Research, Inc.
    Date Cleared
    2020-02-06

    (195 days)

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

    Hyperfine Research, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lucy Point-of-Care Magnetic Resonance Imaging Device is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
    Device Description
    Lucy is a magnetic resonance imaging (MRI) device. Its portability allows patient bedside imaging. It enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off the shelf device, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. Lucy can generate MRI data sets with a broad range of contrasts. The user interface includes touch screen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery.
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