Vendor
12 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Hyperfine, Inc.
Authorized purpose: Swoop Portable MR Imaging System provides ultra-low-field point-of-care head MRI for all ages and includes deep-learning T1, T2, FLAIR, and DWI reconstruction.
Hyperfine, Inc.
Authorized purpose: Swoop Portable MR Imaging System V2 is a portable ultra-low-field MR system for head imaging in adult and pediatric patients, including neonates, at the point of care when a conventional full diagnostic MRI examination is impractical.
Hyperfine, Inc.
Authorized purpose: Swoop Portable MR Imaging System is a portable ultra-low-field MR system for head imaging in adult and pediatric patients at the point of care when conventional full diagnostic MRI is impractical.
Hyperfine, Inc.
Authorized purpose: Swoop Portable MR Imaging System is a portable ultra-low-field MR system for point-of-care head imaging in adult and pediatric patients when a conventional full diagnostic MRI examination is impractical.
Hyperfine, Inc.
Authorized purpose: The Swoop Portable MR Imaging System is a portable, ultra-low-field, bedside magnetic-resonance device for producing images that display the internal structure of the head where a full diagnostic examination is not clinically practical; a trained physician interprets the images.
Hyperfine, Inc.
Authorized purpose: The Swoop Portable MR Imaging System is a bedside magnetic-resonance device for producing images that display the internal structure of the head where a full diagnostic examination is not clinically practical; a trained physician interprets the images for information useful in determining a diagnosis.
Hyperfine, Inc.
Authorized purpose: Automatically labels, measures, and quantifies brain structures from specified low-field MR images.
Hyperfine, Inc.
Authorized purpose: 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 a full diagnostic examination is not clinically practical; a trained physician interprets the images.
Hyperfine, Inc.
Authorized purpose: Swoop Portable MR Imaging System is a point-of-care head MRI system for adult and pediatric patients, including settings such as emergency, critical care, hospital, and rehabilitation where a full diagnostic examination may not be practical; trained physicians interpret the images.
Hyperfine, Inc.
Authorized purpose: Automatically labels, spatially measures, and volumetrically quantifies brain structures from low-field MR images and returns annotated/segmented images, color overlays, and reports.
Hyperfine, Inc.
Authorized purpose: Swoop Portable MR Imaging System is a point-of-care head MRI system for adult and pediatric patients in emergency, critical-care, hospital, and rehabilitation settings where a full diagnostic examination may not be practical; the cleared release includes the submission-specific Swoop 2 changes.
Hyperfine, Inc.
Authorized purpose: Swoop Point-of-Care Magnetic Resonance Imaging Scanner System provides point-of-care MR images of the head for the labeled adult and pediatric workflow, with interpretation and clinical decisions remaining with trained physicians.