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Indications for use vary depending on the specific product and its intended application. These products are designed for use in medical or laboratory settings by trained professionals. Depending on the device, intended uses may include: * **Diagnostic purposes:** Analyzing biological samples (e.g., blood, urine, tissue) to identify diseases, conditions, or other health markers. This can include detecting infections, monitoring chronic illnesses, or screening for genetic predispositions. * **Therapeutic procedures:** Assisting in or performing medical interventions, such as administering medications, delivering fluids, or providing respiratory support. * **Research and development:** Used in laboratory experiments and studies to investigate biological processes, test new drugs, or develop new medical technologies. * **Monitoring physiological parameters:** Measuring heart rate, blood pressure, oxygen saturation, or other vital signs. * **Sample collection and preparation:** Gathering, processing, and storing biological samples for further analysis. Specific indications for use are provided in the product's labeling, instructions for use (IFU), or accompanying documentation. Users should always refer to the manufacturer's provided information for the most accurate and complete indications.

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The Swoop Portable MR Imaging System is a portable, ultra-low field 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.

The Swoop system is portable, ultra-low field MRI device that 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 that is used for operating the system, providing access to patient data, exam setup, exam execution, viewing MRI image data for quality control purposes, and cloud storage interactions. The system can generate MRI data sets with a broad range of contrasts. The Swoop system user interface includes touch screen menus, controls, indicators, and navigation icons that allow the operator to control the system and to view imagery. The Swoop System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, FLAIR, and DWI sequences. The subject Swoop System described in this submission includes software modifications related to the pulse sequences and image processing.

The Swoop Portable MR Imaging System is a portable, ultra-low field 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.

The Swoop system is portable, ultra-low field MRI device that 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 that is used for operating the system, providing access to patient data, exam setup, exam execution, viewing MRI image data for quality control purposes, and cloud storage interactions. The system can generate MRI data sets with a broad range of contrasts. The Swoop system user interface includes touch screen menus, controls, indicators, and navigation icons that allow the operator to control the system and to view imagery. The Swoop System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, FLAIR, and DWI sequences.

The Swoop Portable MR Imaging System is a portable, ultra-low field 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.

The Swoop system is portable, ultra-low field MRI device that 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 that is used for operating the system, providing access to patient data, exam setup, exam execution, viewing MRI image data for quality control purposes, and cloud storage interactions. The system can generate MRI data sets with a broad range of contrasts. The Swoop system user interface includes touch screen menus, controls, indicators, and navigation icons that allow the operator to control the system and to view imagery. The Swoop System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, and FLAIR sequences, specifically in terms of reductions in image noise and blurring.

The Swoop® Portable MR Imaging System™ 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 interreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The Swoop system is a portable MRI device that allows for patient bedside imaging. The system 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 that is used for operating the system, providing access to patient data, exam setup, exam execution, viewing MRI image data for quality control purposes, and cloud storage interactions. The system can generate MRI data sets with a broad range of contrasts. The Swoop system user interface includes touch screen menus, controls, indicators, and navigation icons that allow the operator to control the system and to view imagery. The Swoop System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, and FLAIR sequences, specifically in terms of reductions in image noise and blurring. The subject Swoop System described in this submission includes software modifications related to the following: - DWI pulse sequence and DWI image reconstruction - Image uniformity correction for all sequence types - Noise correction for all sequence types

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 and segmented images, color overlays and reports.

BrainInsight is a fully automated MR imaging post-processing medical software that provides image alignment, whole brain segmentation, ventricle segmentation, and midline shift measurements of brain structures from a set MR images. The BrainInsight processing architecture includes a proprietary automated internal pipeline based on machine learning tools. The output annotated and segmented images are provided in 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 in assessment of low-field (0.064 T) structural MRIs. BrainInsight provides overlays and reports based on 0.064 T 3D MRI series of T1 Gray/White, T2-Fast, and FLAIR images.

The Swoop® Portable MR Imaging System™ 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.

The Swoop system is a portable MRI device that allows for patient bedside imaging. The system 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 that is used for operating the system, providing access to patient data, exam setup, exam execution, viewing MRI image data for quality control purposes, and cloud storage interactions. The system can generate MRI data sets with a broad range of contrasts. The Swoop system user interface includes touch screen menus, controls, indicators, and navigation icons that allow the operator to control the system and to view imagery. The Swoop System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, and FLAIR sequences, specifically in terms of reductions in image noise and blurring. The subject Swoop System described in this submission includes software modifications related to the device pulse sequences; retrained advanced reconstruction models; service and support features; and adds an audible scanner startup tone.

The Swoop® Portable MR Imaging System™ 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.

The Swoop® system is a portable MRI device that allows for patient bedside imaging. The system 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 that is used for operating the system, providing access to patient data, exam setup, exam execution, viewing MRI image data for quality control purposes, and cloud storage interactions. The 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. The Swoop® system image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, and FLAIR sequences, specifically in terms of reductions in image noise and blurring.

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 and segmented images, color overlans and reports.

BrainInsight is a fully automated MR imaging post-processing medical software that provides image alignment, whole brain segmentation, ventricle segmentation, and midline shift measurements of brain structures from a set of MR images from patients ages 18 years or older. The BrainInsight processing architecture includes a proprietary automated internal pipeline based on machine learning tools. The output annotated and segmented images are provided in 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 modified BrainInsight described in this submission includes changes to the machine learning models to allow for the processing Al-reconstructed low-field MR images. The modified device also includes configuration updates and refactoring changes for incremental improvement.

The Swoop® Portable MR Imaging System 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.

The Swoop® system is a portable MRI device that allows for patient bedside imaging. The system 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 that is used for operating the system, providing access to patient data, exam setup, exam execution, viewing MRI image data for quality control purposes, and cloud storage interactions. The system can generate MRI data sets with a broad range of contrasts. The Swoop® system user interface includes touch screen menus, controls, indicators, and navigation icons that allow the operator to control the system and to view imagery. The Swoop® System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, and FLAIR sequences, specifically in terms of reductions in image noise and blurring. This subject device in this submission includes modified pulse sequence options and an enhancement to the existing noise correction feature to remove residual line noise.