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Hyperfine, Inc. FDA Approvals
0 new drug approvals and 14 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Swoop® Portable MR Imaging® System510(k)Aug 19, 2026Radiology |
| Swoop® Portable MR Imaging® System510(k)Dec 12, 2025Radiology |
| Swoop® Portable MR Imaging® System (V2)510(k)May 30, 2025Radiology |
| Swoop® Portable MR Imaging® System510(k)May 21, 2025Radiology |
| Swoop® Portable MR Imaging® System510(k)Jul 16, 2024Radiology |
| Swoop® Portable MR Imaging System®510(k)Oct 6, 2023Radiology |
| Swoop® Portable MR Imaging System510(k)Feb 22, 2023Radiology |
| BrainInsight510(k)Dec 16, 2022Radiology |
| Swoop Portable MR Imaging System510(k)Dec 6, 2022Radiology |
| Swoop Portable MR Imaging System510(k)Jul 28, 2022Radiology |
| BrainInsight510(k)Jul 19, 2022Radiology |
| Swoop Portable MR Imaging System510(k)Jun 10, 2022Radiology |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System510(k)Nov 17, 2021Radiology |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System510(k)Jul 7, 2021Radiology |