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Sign in to claim this brandHyperfine Operations, Inc.
US
Last updated May 31, 2026
What Hyperfine Operations, Inc. makes
Hyperfine Operations, Inc. manufactures portable magnetic resonance imaging (MRI) systems, including the Swoop POC MRI Scanner, a permanent magnet extremity MRI device designed for point-of-care use. The company also produces radio-frequency head coils, such as the Swoop Transmit and Receive RF Head Coil, tailored for high-resolution imaging. Additionally, it develops software applications for image segmentation, including BrainInsight, which aids in analyzing MRI scans.
The company’s devices fall under Class II regulatory classification in the U.S. and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use within the United States, adhering to applicable FDA requirements for medical imaging systems and software.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- hyperfine.io
- —
- —
- [email protected]
- Phone
- 775-476-2674
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 051795046
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BrainInsight | Version 1.0 | FDA UDI | Class II | Active |
| Swoop Transmit and Receive Radio Frequency Head Coil | 850-11016-05 | FDA UDI | Class II | Active |
| Swoop Point-of-Care Magnetic Resonance Imaging Scanner | V1.7 (850-11001-04) | FDA UDI | Class II | Active |
| Swoop Transmit and Receive Radio Frequency Head Coil | V2.0 (815-11016-04) | EUDAMEDFDA UDI | Class II | Active |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner | 850-11001-05 | FDA UDI | Class II | Active |
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