Medical Device Manufacturer · US , Guildford , CT

Hyperfine, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2021

Recent clearances: Swoop® Portable MR Imaging® System, Swoop® Portable MR Imaging® System (V2), Swoop® Portable MR Imaging® System

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hyperfine, Inc. Radiology ✕

13 devices

1-12 of 13

Cleared Dec 12, 2025

Swoop® Portable MR Imaging® System

Radiology · 49d

Cleared May 30, 2025

Swoop® Portable MR Imaging® System (V2)

Radiology · 123d

Cleared May 21, 2025

Swoop® Portable MR Imaging® System

Radiology · 27d

Cleared Jul 16, 2024

Swoop® Portable MR Imaging® System

Radiology · 102d

Cleared Oct 06, 2023

Swoop® Portable MR Imaging System®

Radiology · 28d

Cleared Feb 22, 2023

Swoop® Portable MR Imaging System™

Radiology · 28d

Cleared Dec 16, 2022

Radiology · 53d

Cleared Dec 06, 2022

Swoop Portable MR Imaging System

Radiology · 46d

Cleared Jul 28, 2022

Swoop Portable MR Imaging System

Radiology · 27d

Cleared Jul 19, 2022

Radiology · 120d

Cleared Jun 10, 2022

Swoop Portable MR Imaging System

Radiology · 28d

Cleared Nov 17, 2021

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Radiology · 104d