Swoop Portable MR Imaging System (V2)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250236 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Swoop Portable MR Imaging System (V2) is a portable nuclear magnetic resonance imaging device designed for magnetic resonance imaging (MRI) applications. It provides high-resolution imaging capabilities without the need for a traditional fixed MRI facility, enabling flexible and accessible diagnostic imaging in various clinical settings.
This system is intended for use in radiology departments and clinical environments where MRI is required but space or infrastructure constraints limit access to conventional MRI machines. The device is supplied as a complete, portable unit and is regulated under FDA 510(k) clearance and MDR compliance. It is classified as a Class II medical device and is intended for single-use or reusable configurations as specified by the manufacturer, with MRI safety ratings detailed in its technical documentation.
Frequently asked questions
What clinical settings is the Swoop® Portable MR Imaging® System (V2) designed to support, and why is portability important for these environments?
The Swoop® Portable MR Imaging® System (V2) is specifically designed for radiology departments and clinical environments where traditional MRI infrastructure is limited by space or infrastructure constraints. Its portability enables flexible imaging solutions in settings like outpatient clinics, mobile health units, or facilities with restricted access to fixed MRI rooms, ensuring diagnostic imaging remains accessible without requiring a dedicated MRI facility.
How is the Swoop® Portable MR Imaging® System (V2) regulated, and what does this mean for its use in clinical practice?
The Swoop® Portable MR Imaging® System (V2) is regulated under both FDA 510(k) clearance and MDR compliance, classifying it as a Class II medical device. This means it has undergone rigorous review to ensure safety and performance, and its use adheres to established regulatory standards for nuclear magnetic resonance imaging systems in radiology settings.
Is the Swoop® Portable MR Imaging® System (V2) intended for single-use or reusable applications, and how should it be handled?
The Swoop® Portable MR Imaging® System (V2) can be configured for either single-use or reusable applications, as specified by the manufacturer. Handling and reprocessing (if reusable) must follow manufacturer guidelines to maintain safety, sterility, and performance, particularly given its use in clinical imaging where contamination risks could compromise diagnostic accuracy.
What types of MRI safety ratings should clinicians consider when using the Swoop® Portable MR Imaging® System (V2) in their facility?
The Swoop® Portable MR Imaging® System (V2) includes MRI safety ratings as detailed in its technical documentation. Clinicians should review these ratings to ensure compatibility with their facility’s existing MRI safety protocols, particularly regarding magnetic field strength, radiofrequency exposure, and safe patient/equipment placement to prevent hazards like projectiles or burns.
How does the portability of this system impact its deployment compared to traditional MRI machines?
Unlike traditional MRI machines, the Swoop® Portable MR Imaging® System (V2) is designed as a complete, portable unit, eliminating the need for a fixed installation. This allows for deployment in locations without dedicated MRI infrastructure, such as remote clinics, emergency departments, or temporary medical facilities, while still delivering high-resolution imaging capabilities.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K250236 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hyperfine, Inc.
Sources (2)
- FDA 510(k) K250236 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026