Swoop Portable MR Imaging System
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Swoop Portable MR Imaging System EUDAMED
- Device Name
- Swoop® Portable MR Imaging® System EUDAMED
- Model / Reference
- 850-11001-06 (900-11001-06, in crate) EUDAMED850-11010-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850043319160 EUDAMED
- Basic UDI-DI
- 0860000606100001R3 EUDAMED
- Direct Marketing DI
- 00850043319160 EUDAMED
- EMDN Code
- Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Full-body MRI system, superconducting magnet
The Swoop Portable MR Imaging System is a portable magnetic resonance imaging (MRI) device designed for point-of-care imaging. Classified under nomenclature code Z11050104, it provides real-time imaging capabilities without requiring traditional MRI infrastructure, enabling flexible deployment in clinical settings.
This non-sterile, non-reusable system is intended for single-use applications and is not implantable or designed for administering medicine. It operates under FDA 510(k) clearance and MDR authorization, with a UDI of 0860000606100001R3. The device is supplied in a portable configuration, requiring no special MRI safety considerations beyond standard electromagnetic interference precautions. Storage and handling follow standard medical imaging protocols.
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Also classified as Full-body MRI system, superconducting magnet.
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Frequently asked questions
Is the Swoop Portable MR Imaging System designed for repeated use in the same patient or single-use only?
The Swoop Portable MR Imaging System is explicitly designed for single-use applications only. The data confirms it is non-reusable (REUSABLE: 0) and not intended for repeated use, even though it is portable and can be moved between different patients or clinical settings.
What safety precautions should be taken when using the Swoop Portable MR Imaging System near other medical devices or equipment?
The Swoop Portable MR Imaging System requires standard electromagnetic interference (EMI) precautions, as noted in the description. While it does not require traditional MRI safety considerations (e.g., shielding or strict room requirements), users should still follow general medical imaging protocols to avoid interference with other electronic devices or equipment in the vicinity.
How is the Swoop Portable MR Imaging System supplied, and what model numbers should I expect?
The Swoop Portable MR Imaging System is supplied in a portable configuration, with the primary model number being 850-11001-06. The system is also packaged in a crate under the model 900-11001-06, which may be relevant for bulk or institutional orders. The device is non-sterile and intended for single-use, so no additional sterilization or reprocessing is required.
Does the Swoop Portable MR Imaging System require any special storage conditions beyond standard medical imaging protocols?
The Swoop Portable MR Imaging System follows standard medical imaging storage and handling protocols, as explicitly stated in the device description. No additional specialized storage conditions (e.g., temperature, humidity, or shielding) are mentioned beyond what would typically apply to portable diagnostic imaging equipment. Always refer to the manufacturer’s instructions for the most current guidance.
What regulatory pathways does the Swoop Portable MR Imaging System follow, and who is the authorized representative in the EU?
The Swoop Portable MR Imaging System is cleared under FDA 510(k) (with a special clearance type and classified as Class IIa) and authorized under the EU MDR (Medical Device Regulation). In the EU, the authorized representative is Emergo Europe B.V. (SRN: NL-AR-000000116), ensuring compliance with European market requirements. The UDI (0860000606100001R3) helps track the device globally.
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
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232760 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K230208 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K223247 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K221923 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K221393 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0860000606100001R3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hyperfine, Inc.
- EUDAMED SRN
- US-MF-000029806
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED dae45e30-43ff-42c0-a456-143ac695bf1c 85 fields · synced Sep 18, 2026
- FDA 510(k) K232760 1 fields · synced May 18, 2026