Medical Device Manufacturer · US , Guildford , CT

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

14 submissions · 14 cleared · Since 2021

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

14
Total
14
Cleared
0
Denied

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

14 devices
1-14 of 14
Cleared Aug 19, 2026
Swoop® Portable MR Imaging® System
K262622 · LNH
Radiology · 22d
Cleared Dec 12, 2025
Swoop® Portable MR Imaging® System
K253489 · LNH
Radiology · 49d
Cleared May 30, 2025
Swoop® Portable MR Imaging® System (V2)
K250236 · LNH
Radiology · 123d
Cleared May 21, 2025
Swoop® Portable MR Imaging® System
K251276 · LNH
Radiology · 27d
Cleared Jul 16, 2024
Swoop® Portable MR Imaging® System
K240944 · LNH
Radiology · 102d
Cleared Oct 06, 2023
Swoop® Portable MR Imaging System®
K232760 · LNH
Radiology · 28d
Cleared Feb 22, 2023
Swoop® Portable MR Imaging System™
K230208 · LNH
Radiology · 28d
Cleared Dec 16, 2022
BrainInsight
K223268 · QIH
Radiology · 53d
Cleared Dec 06, 2022
Swoop Portable MR Imaging System
K223247 · LNH
Radiology · 46d
Cleared Jul 28, 2022
Swoop Portable MR Imaging System
K221923 · LNH
Radiology · 27d
Cleared Jul 19, 2022
BrainInsight
K220815 · QIH
Radiology · 120d
Cleared Jun 10, 2022
Swoop Portable MR Imaging System
K221393 · LNH
Radiology · 28d
Cleared Nov 17, 2021
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K212456 · LNH
Radiology · 104d
Cleared Jul 07, 2021
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K211818 · LNH
Radiology · 26d
Filters
Filter by Specialty
All14 Radiology 14