FDA-cleared K253489

Swoop® Portable MR Imaging® System

Hyperfine, Inc.

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.

Modality
MRI
Anatomy
Brain
Decision
2025-12-12
FDA-cleared K250236

Swoop® Portable MR Imaging® System (V2)

Hyperfine, Inc.

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...

Modality
MRI
Anatomy
Brain
Decision
2025-05-30
FDA-cleared K251276

Swoop® Portable MR Imaging® System

Hyperfine, Inc.

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...

Modality
MRI
Anatomy
Brain
Decision
2025-05-21
FDA-cleared K240944

Swoop® Portable MR Imaging® System

Hyperfine, Inc.

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...

Modality
MRI
Anatomy
Brain
Decision
2024-07-16
FDA-cleared K232760

Swoop® Portable MR Imaging System®

Hyperfine, Inc.

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...

Modality
MRI
Anatomy
Head
Decision
2023-10-06
FDA-cleared K230208

Swoop® Portable MR Imaging System™

Hyperfine, Inc.

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...

Modality
MRI
Anatomy
Head
Decision
2023-02-22
FDA-cleared K223268

BrainInsight

Hyperfine, Inc.

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...

Modality
MRI
Anatomy
Brain
Decision
2022-12-16
FDA-cleared K223247

Swoop Portable MR Imaging System

Hyperfine, Inc.

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...

Modality
MRI
Anatomy
Head
Decision
2022-12-06
FDA-cleared K221923

Swoop Portable MR Imaging System

Hyperfine, Inc.

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...

Modality
MRI
Anatomy
Head
Decision
2022-07-28
FDA-cleared K220815

BrainInsight

Hyperfine, Inc.

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...

Modality
MRI
Anatomy
Brain
Decision
2022-07-19
FDA-cleared K221393

Swoop Portable MR Imaging System

Hyperfine, Inc.

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...

Modality
MRI
Anatomy
Head
Decision
2022-06-10