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Sign in to claim this brandHyperfine, Inc.
United States·US-MF-000029806
Last updated September 18, 2026
About
The Hyperfine, Inc. Swoop® Portable MR Imaging® system brings brain imaging to the patient at the point of care.
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 351, New Whitfield Street, Guilford, CT, United States
- Website
- www.hyperfine.io
- linkedin.com/company/hyperfine-inc
- facebook.com/Hyperfine
- [email protected]
- Phone
- —
- PRRC Contact
- Robert Fasciano
- EUDAMED SRN
- US-MF-000029806
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BrainInsight | K223268 | FDA 510(k) | Class II | Active |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | K212456 | FDA 510(k) | Class II | Active |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | K211818 | FDA 510(k) | Class II | Active |
| Swoop® Portable MR Imaging® System (V2) | K250236 | FDA 510(k) | Class II | Active |
| BrainInsight | K220815 | FDA 510(k) | Class II | Active |
| Swoop® Portable MR Imaging® System | 900-11001-06 | EUDAMEDFDA UDI | Class IIa | Active |
| Back Pad | 810-11113-00 | EUDAMED | Class I | Active |
| Foam Head Pad | 900-11021-00 | EUDAMEDFDA UDI | Class I | Active |
| Swoop Portable MR Imaging System | 850-11010-02 | EUDAMED | Class IIa | Active |
| Head Stabilizer | 900-11022-00 | EUDAMEDFDA UDI | Class I | Active |
| SQA Phantom (MRI Quality Assurance Phantom) | 810-11049-01 | EUDAMEDFDA UDI | Class I | Active |
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