Data / Medical devices / United States / Hyperfine, Inc
Hyperfine, Inc: FDA-registered device maker in Guilford, CT, United States, 2 510(k) clearances
Hyperfine, Inc is registered with the FDA (registration 3014310698) in Guilford, CT, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014310698
- Address
- 351 New Whitfield Street, Guilford, CT, United States, 06437
- Owner or operator
- Hyperfine, Inc. (10077154)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 21, 2022
- Registered through
- 2026
- Brand names listed
- Back Cushion, BrainInsight, Foam Had Pad, Head Stabilizer, Swoop Portable MR Imaging System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Manufacturer | accessdata.fda.gov |
| Cradle, Patient, Radiologic | KXH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Holder, Head, Radiographic | IWY | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 12, 2025 | K253489 | Swoop® Portable MR Imaging® System | LNH | Substantially Equivalent | Hyperfine, Inc. | accessdata.fda.gov |
| December 16, 2022 | K223268 | BrainInsight | QIH | Substantially Equivalent | Hyperfine, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of Holder, Head, Radiographic
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of Cradle, Patient, Radiologic
Updated December 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.