Hyperfine, Inc. is one of 16108 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Hyperfine, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Swoop® Portable MR Imaging® System, Swoop® Portable MR Imaging® System, Swoop® Portable MR Imaging® System (V2)
14
Total
14
Cleared
0
Denied
Hyperfine, Inc. has 14 FDA 510(k) cleared radiology devices. Based in Guildford, US.
Latest FDA clearance: Aug 2026. Active since 2021.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Hyperfine, Inc.
14 devices
Cleared
Aug 19, 2026
Swoop® Portable MR Imaging® System
Radiology
22d
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
BrainInsight
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
BrainInsight
Radiology
120d
Cleared
Jun 10, 2022
Swoop Portable MR Imaging System
Radiology
28d